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Completed

NCT Number: NCT03436849

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESN364 in Healthy Japanese Male and Pre- and Post-menopausal Female Subjects

The purpose of this study is to evaluate the safety and tolerability of single and multiple oral doses of ESN364 in healthy Japanese male and pre- and post-menopausal female subjects. This study will also evaluate the pharmacokinetics (PK) of ESN364 and its metabolite, and the pharmacodynamics (PD) of ESN364 after single and multiple oral doses administration in healthy Japanese male and pre- and post-menopausal female subjects.

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Key information

Conditions

Healthy Subjects

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site JP00001

Fukuoka, Japan

About this study

This study consists of two parts. Part 1; Single Dose (SD) and Part 2; Single and Multiple Dose (SD and MD).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male subject between 20 to < 45 years of age, or female subject between 20 to < 65 years of age.
  • Body weight at screening: ≥ 50.0 kg and < 80.0 kg for male, ≥ 40.0 kg and < 70.0 kg for female.
  • Body mass index (BMI) at screening: range of ≥ 17.6 kg/m2 and < 26.4 kg/m2 [BMI = Body weight (kg) ÷ {Body height (m)2}].

Exclusion criteria

  • Subjects who participated or are scheduled to participate in any clinical trials or post-marketing studies within 84 days prior to screening.
  • Subject has had previous exposure with ESN364.
  • Subject has any clinically significant history of allergic conditions prior to study drug administration.
  • Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy.
  • Subject has contracted pyretic or symptomatic viral, bacterial, or fungal infection within 7 days prior to hospital admission.
  • Any deviation from the normal range of blood pressure, pulse, body temperature, or routine 12-lead ECG at screening or on the day of hospital admission.
  • Subjects who has any significantly abnormal results of laboratory tests at screening or on the day of hospital admission.
  • Subjects who are positive for any of urinary drug abuse test or serology test at screening.
  • Subject took a drug or underwent therapy within 2 weeks prior to hospital admission.
  • Subjects used a drug or underwent therapy that affects sex hormones within 3 months prior to hospital admission.
  • Subjects who had bilateral orchiectomy.
  • Subject has used any inducer of metabolism in the 3 months prior to hospital admission.
  • Subject has a history of smoking more than 10 cigarettes per day within 3 months prior to screening test.
  • Subject consumes, on average, more than approximately 500 mg/day of caffeine
  • Subject has a history of consuming more than 30 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years prior to screening.
  • Subjects who conducted or is scheduled to conduct any blood donation or blood drawing.

Treatment and study plan

ESN364

Drug

ESN364 will be administered orally.

Placebo

Drug

Placebo will be administered orally.

Primary outcomes

  1. Safety assessed by incidence of adverse events (AEs) in Part 1

    Time frame: Up to Day 12 in Part 1

    AEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA).

  2. Safety assessed by incidence of AEs in Part 2

    Time frame: Up to Day 24 in Part 2

    AEs will be coded using MedDRA.

  3. Safety assessed by vital signs: Body temperature in Part 1

    Time frame: Up to day 12 in Part 1

    To assess vital signs as a criterion of safety variables.

  4. Safety assessed by vital signs: Body temperature in Part 2

    Time frame: Up to Day 24 in Part 2

    To assess vital signs as a criterion of safety variables.

  5. Safety assessed by vital signs: Blood pressure in Part 1

    Time frame: Up to Day 12 in Part 1

    To assess vital signs as a criterion of safety variables.

  6. Safety assessed by vital signs: Blood pressure in Part 2

    Time frame: Up to Day 24 in Part 2

    To assess vital signs as a criterion of safety variables.

  7. Safety assessed by vital signs: Pulse rate in Part 1

    Time frame: Up to Day 12 in Part 1

    To assess vital signs as a criterion of safety variables.

  8. Safety assessed by vital signs: Pulse rate in Part 2

    Time frame: Up to Day 24 in Part 2

    To assess vital signs as a criterion of safety variables.

  9. Safety assessed by laboratory test: Hematology in Part 1

    Time frame: Up to Day 12 in Part 1

    To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.

  10. Safety assessed by laboratory test: Hematology in Part 2

    Time frame: Up to Day 24 in Part 2

    To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.

  11. Safety assessed by laboratory test: Biochemistry in Part 1

    Time frame: Up to Day 12 in Part 1

    To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.

  12. Safety assessed by laboratory test: Biochemistry in Part 2

    Time frame: Up to Day 24 in Part 2

    To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.

  13. Safety assessed by laboratory test: Urinalysis in Part 1

    Time frame: Up to Day 12 in Part 1

    To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.

  14. Safety assessed by laboratory test: Urinalysis in Part 2

    Time frame: Up to Day 24 in Part 2

    To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.

  15. Safety assessed by standard 12-lead electrocardiogram (ECG) in Part 1

    Time frame: Up to Day 12 in Part 1

    Subjects should keep rest for 5 minutes before evaluation. Any clinically significant adverse changes on the ECG will be reported as AEs.

  16. Safety assessed by standard ECG in Part 2

    Time frame: Up to Day 24 in Part 2

    Subjects should keep rest for 5 minutes before evaluation. Any clinically significant adverse changes on the ECG will be reported as AEs.

  17. Safety assessed by ECG parameters: Heart rate in Part 1

    Time frame: Up to 24 hr after dosing in Part 1

    To assess ECG parameters as a criterion of safety variables.

  18. Safety assessed by ECG parameters: Heart rate in Part 2

    Time frame: Up to 24 hr after dosing on Day 10 in multiple dose (MD) of Part 2

    To assess ECG parameters as a criterion of safety variables.

  19. Safety assessed by ECG parameters: QT interval in Part 1

    Time frame: Up to 24 hr after dosing in Part 1

    To assess ECG parameters as a criterion of safety variables.

  20. Safety assessed by ECG parameters: QT interval in Part 2

    Time frame: Up to 24 hr after dosing on Day 10 in MD of Part 2

    To assess ECG parameters as a criterion of safety variables.

  21. Safety assessed by ECG parameters: RR interval in Part 1

    Time frame: Up to 24 hr after dosing in Part 1

    To assess ECG parameters as a criterion of safety variables.

  22. Safety assessed by ECG parameters: RR interval in Part 2

    Time frame: Up to 24 hr after dosing on Day 10 in MD of Part 2

    To assess ECG parameters as a criterion of safety variables.

  23. Safety assessed by ECG parameters: PR interval in Part 1

    Time frame: Up to 24 hr after dosing in Part 1

    To assess ECG parameters as a criterion of safety variables.

  24. Safety assessed by ECG parameters: PR interval in Part 2

    Time frame: Up to 24 hr after dosing on Day 10 in MD of Part 2

    To assess ECG parameters as a criterion of safety variables.

  25. Safety assessed by ECG parameters: QRS interval in Part 1

    Time frame: Up to 24 hr after dosing in Part 1

    To assess ECG parameters as a criterion of safety variables.

  26. Safety assessed by ECG parameters: QRS interval in Part 2

    Time frame: Up to 24 hr after dosing on Day 10 in MD of Part 2

    To assess ECG parameters as a criterion of safety variables.

  27. Safety assessed by ECG parameters: QTc interval corrected by Fridericia method (QTcF) in Part 1

    Time frame: Up to 24 hr after dosing in Part 1

    To assess ECG parameters as a criterion of safety variables.

  28. Safety assessed by ECG parameters: QTcF in Part 2

    Time frame: Up to 24 hr after dosing on Day 10 in MD of Part 2

    To assess ECG parameters as a criterion of safety variables.

  29. Safety assessed by body weight in Part 1

    Time frame: Up to Day 3 in Part 1

    To assess body weight as a criterion of safety variables

  30. Safety assessed by body weight in Part 2

    Time frame: Up to Day 15 in Part 2

    To assess body weight as a criterion of safety variables

  31. Safety assessed by menstrual cycle in pre-menopausal females

    Time frame: Up to an average of two weeks after last dosing

    To assess menstrual cycle as a criterion of safety variables

Secondary outcomes

  1. Pharmacokinetics (PK) parameter for ESN364 and its metabolite: Area under the concentration-time curve (AUC) from the time of dosing to time 24 h (AUC24) in plasma

    Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2

    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.

  2. PK parameter for ESN364 and its metabolite: AUC from the time of dosing extrapolated to time infinity (AUCinf) in plasma

    Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2

    To assess the PK of ESN364 and its metabolite4 in Part 1 and Part 2.

  3. PK parameter for ESN364 and its metabolite: Percentage of AUCinf (AUCinf(%extrap)) in plasma

    Time frame: Up to 48 hr after dosing in Part 1

    To assess the PK of ESN364 and its metabolite in Part 1.

  4. PK parameter for ESN364 and its metabolite: AUC from the time of dosing to the last measurable concentration (AUClast) in plasma

    Time frame: Up to 48 hr after dosing in Part 1

    To assess the PK of ESN364 and its metabolite in Part 1.

  5. PK parameter for ESN364 and its metabolite: Maximum concentration (Cmax) in plasma

    Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.

  6. PK parameter for ESN364 and its metabolite: Apparent total clearance after extra-vascular dosing (CL/F) in plasma

    Time frame: Up to 48 hr after dosing in Part 1 and after dosing on Day 10 in MD part of Part 2

    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.

  7. PK parameter for ESN364 and its metabolite: Time point prior to the time point corresponding to the first measurable (non-zero) concentration (tlag) in plasma

    Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.

  8. PK parameter for ESN364 and its metabolite: Time of the maximum concentration： (tmax) in plasma

    Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.

  9. PK parameter for ESN364 and its metabolite: Terminal elimination half-life (t1/2) in plasma

    Time frame: Up to 48 hr after dosing in Part 1 and after dosing on Day 10 in MD part of Part 2

    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.

  10. PK parameter for ESN364 and its metabolite: volume of distribution during the terminal elimination phase after extra-vascular dosing (Vz/F) in plasma

    Time frame: Up to 48 hr after dosing in Part 1 and after dosing on Day 10 in MD part of Part 2

    To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.

  11. PK parameter for ESN364 metabolite: Metabolite to parent ratio (MPR) in plasma

    Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PK of ESN364 metabolite in Part 1 and Part 2.

  12. PK parameter for ESN364 and its metabolite: AUC from the time of dosing to the start of the next dosing interval (AUCtau) in plasma

    Time frame: Up to 48 hr after dosing on Day 10 in MD part of Part 2

    To assess the PK of ESN364 and its metabolite in Part 2.

  13. PK parameter for ESN364 and its metabolite: Peak-trough ratio (PTR) in plasma

    Time frame: Up to 48 hr after dosing on Day 10 in MD part of Part 2

    To assess the PK of ESN364 and its metabolite in Part 2.

  14. PK parameter for ESN364 and its metabolite: Accumulation ratio calculated using AUC (Rac(AUC)) in plasma

    Time frame: Up to 48 hr after dosing on Day 10 in MD part of Part 2

    To assess the PK of ESN364 and its metabolite in Part 2.

  15. PK parameter for ESN364 and its metabolite: Concentration immediately prior to dosing at multiple dosing (Ctrough) in plasma

    Time frame: Before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2

    To assess the PK of ESN364 and its metabolite in Part 2.

  16. Pharmacodynamic (PD) endpoint for ESN364: Luteinizing hormone (LH) level in plasma

    Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  17. PD endpoint for ESN364: AUC12 for LH level

    Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.

    To assess the PD of ESN364 in Part 1 and Part 2.

  18. PD endpoint for ESN364: AUC24 for LH level

    Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.

    To assess the PD of ESN364 in Part 1 and Part 2.

  19. PD endpoint for ESN364: AUC48 for LH level

    Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.

    To assess the PD of ESN364 in Part 1 and Part 2.

  20. PD endpoint for ESN364: Cmin for LH level

    Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  21. PD endpoint for ESN364: tmin for LH level

    Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  22. PD endpoint for ESN364: AUC from the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) for LH level

    Time frame: Before dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 2.

  23. PD endpoint for ESN364: Cpredose for LH level

    Time frame: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  24. PD endpoint for ESN364: Follicle stimulating hormone (FSH) level in plasma

    Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  25. PD endpoint for ESN364: AUC12 for FSH level

    Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.

    To assess the PD of ESN364 in Part 1 and Part 2.

  26. PD endpoint for ESN364: AUC24 for FSH level

    Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.

    To assess the PD of ESN364 in Part 1 and Part 2.

  27. PD endpoint for ESN364: AUC48 for FSH level

    Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.

    To assess the PD of ESN364 in Part 1 and Part 2.

  28. PD endpoint for ESN364: Cmin for FSH level

    Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  29. PD endpoint for ESN364: tmin for FSH level

    Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  30. PD endpoint for ESN364: AUCtau for FSH level

    Time frame: Before dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 2.

  31. PD endpoint for ESN364: Cpredose for FSH level

    Time frame: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  32. PD endpoint for ESN364: Sex hormone binding globulin (SHBG) level in plasma

    Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  33. PD endpoint for ESN364: AUC12 for SHBG level

    Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.

    To assess the PD of ESN364 in Part 1 and Part 2.

  34. PD endpoint for ESN364: AUC24 for SHBG level

    Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.

    To assess the PD of ESN364 in Part 1 and Part 2.

  35. PD endpoint for ESN364: AUC48 for SHBG level

    Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.

    To assess the PD of ESN364 in Part 1 and Part 2.

  36. PD endpoint for ESN364: Cmin for SHBG level

    Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  37. PD endpoint for ESN364: tmin for SHBG level

    Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  38. PD endpoint for ESN364: AUCtau for SHBG level

    Time frame: Before dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 2.

  39. PD endpoint for ESN364: Cpredose for SHBG level

    Time frame: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  40. PD endpoint for ESN364: Total testosterone (TT) level in plasma

    Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  41. PD endpoint for ESN364: AUC24 for TT level

    Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.

    To assess the PD of ESN364 in Part 1 and Part 2.

  42. PD endpoint for ESN364: AUC12 for TT level

    Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.

    To assess the PD of ESN364 in Part 1 and Part 2.

  43. PD endpoint for ESN364: AUC48 for TT level

    Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.

    To assess the PD of ESN364 in Part 1 and Part 2.

  44. PD endpoint for ESN364: Cmin for TT level

    Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  45. PD endpoint for ESN364: tmin for TT level

    Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  46. PD endpoint for ESN364: AUCtau for TT level

    Time frame: Before dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 2.

  47. PD endpoint for ESN364: Cpredose for TT level

    Time frame: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  48. PD endpoint for ESN364: Free testosterone (FT) level in plasma

    Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  49. PD endpoint for ESN364: AUC12 for FT level

    Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.

    To assess the PD of ESN364 in Part 1 and Part 2.

  50. PD endpoint for ESN364: AUC24 for FT level

    Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.

    To assess the PD of ESN364 in Part 1 and Part 2.

  51. PD endpoint for ESN364: AUC48 for FT level

    Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.

    To assess the PD of ESN364 in Part 1 and Part 2.

  52. PD endpoint for ESN364: Cmin for FT level

    Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  53. PD endpoint for ESN364: tmin for FT level

    Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  54. PD endpoint for ESN364: AUCtau for FT level

    Time frame: Before dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 2.

  55. PD endpoint for ESN364: Cpredose for FT level

    Time frame: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2

    To assess the PD of ESN364 in Part 1 and Part 2.

  56. PD endpoint for ESN364: Estradiol (E) level in plasma

    Time frame: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in female subjects in Part 2.

  57. PD endpoint for ESN364: AUC12 for E level

    Time frame: Up to 48 hr after first dosing in Part 2.

    To assess the PD of ESN364 in female subjects in Part 2.

  58. PD endpoint for ESN364: AUC24 for E level

    Time frame: Up to 48 hr after first dosing in Part 2.

    To assess the PD of ESN364 in female subjects in Part 2.

  59. PD endpoint for ESN364: AUC48 for E level

    Time frame: Up to 48 hr after first dosing in Part 2.

    To assess the PD of ESN364 in female subjects in Part 2.

  60. PD endpoint for ESN364: Cmin for E level

    Time frame: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in female subjects in Part 2.

  61. PD endpoint for ESN364: tmin for E level

    Time frame: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in female subjects in Part 2.

  62. PD endpoint for ESN364: AUCtau for E level

    Time frame: Before dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in female subjects in Part 2.

  63. PD endpoint for ESN364: Cpredose for E level

    Time frame: Before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2

    To assess the PD of ESN364 in female subjects in Part 2.

  64. PD endpoint for ESN364: Progesterone (P) level in plasma

    Time frame: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in female subjects in Part 2.

  65. PD endpoint for ESN364: AUC12 for P level

    Time frame: Up to 48 hr after first dosing in Part 2.

    To assess the PD of ESN364 in female subjects in Part 2.

  66. PD endpoint for ESN364: AUC24 for P level

    Time frame: Up to 48 hr after first dosing in Part 2.

    To assess the PD of ESN364 in female subjects in Part 2.

  67. PD endpoint for ESN364: AUC48 for P level

    Time frame: Up to 48 hr after first dosing in Part 2.

    To assess the PD of ESN364 in female subjects in Part 2.

  68. PD endpoint for ESN364: Cmin for P level

    Time frame: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in female subjects in Part 2.

  69. PD endpoint for ESN364: tmin for P level

    Time frame: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in female subjects in Part 2.

  70. PD endpoint for ESN364: AUCtau for P level

    Time frame: Before dosing on Day 10 in MD part of Part 2

    To assess the PD of ESN364 in female subjects in Part 2.

  71. PD endpoint for ESN364: Cpredose for P level

    Time frame: Before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2

    To assess the PD of ESN364 in female subjects in Part 2.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Phase 1 Study of ESN364 - Placebo-controlled, Single and Multiple Oral Dose Study in Healthy Japanese Male and Healthy Japanese Pre- and Postmenopausal Female Subjects -

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 19, 2018
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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