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Completed

NCT Number: NCT03183739

Study to Evaluate the Safety and Tolerability of ASP8062 in Healthy Japanese Male and Female Subjects

The purpose of this study is to evaluate the safety and tolerability and evaluate pharmacokinetics of single and multiple ascending oral doses of ASP8062 in nonelderly Japanese male and female subjects.

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Key information

Conditions

Age range

20 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site JP00001

Sumida City, Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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: ≥ 17.6 kg/m^2 and < 26.4 kg/m^2 [BMI = Body weight (kg) ÷ {Body height (m)^2}].
  • Female subjects must agree to consistently use 2 forms of highly effective birth control starting at screening and throughout the study period and for 28 days after the final study drug administration.
  • Female subjects must not donate ova starting at informed consent and throughout the clinical study period, and for 28 days after the final study drug administration.
  • Male subjects and female spouse/partners who are of childbearing potential must be using condom and one of the highly effective birth control starting informed consent throughout the clinical study period and for 90 days after final study drug, if vasectomy is not performed for male subjects.
  • Male subjects must not donate sperm starting at informed consent and throughout the clinical study period, and for 90 days after study drug administration.

Exclusion criteria

  • Subjects who participated or are scheduled to participate in any clinical trials or post-marketing studies within 120 days before screening test or during the screening test to the hospital admission (Day -2).
  • Subjects who received or is scheduled to receive any medications (including over-the-counter drugs) within seven days before the 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 (Day -1).
  • Subjects who meet any of the criterion for laboratory tests at screening or on the day of hospital admission (Day -2).
  • Any deviation from the normal range of routine 12-lead ECG at screening.
  • Subjects with a complication or history of drug allergies.
  • Subjects who developed upper gastrointestinal symptoms (nausea, vomiting, stomachache, etc.) within seven days before the hospital admission.
  • Subjects with a history of gastrointestinal resection except for appendicitis.
  • Subjects with a complication or history of hepatic disease, cardiac disease, respiratory disease, gastrointestinal disease, renal disease, endocrine disease, cerebrovascular disease or malignant tumor.
  • Subjects who received ASP8062 previously.
  • Subject has a relevant history of suicide attempt or suicidal behavior.

Treatment and study plan

ASP8062

Drug

ASP8062 will be administered orally.

Placebo

Drug

Placebo will be administered orally.

Primary outcomes

  1. Safety assessed by incidence of adverse events

    Time frame: Up to Day 38

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

  2. Safety assessed by vital signs: supine blood pressure

    Time frame: Up to Day 38

    To assess the vital sign as a criteria of safety and tolerability variables.

  3. Safety assessed by vital signs: supine pulse rate

    Time frame: Up to Day 38

    To assess the vital sign as a criteria of safety and tolerability variables.

  4. Safety assessed by vital signs: axillary body temperature

    Time frame: Up to Day 38

    To assess the vital sign as a criteria of safety and tolerability variables.

  5. Orthostatic challenge tests

    Time frame: Up to Day 20

    To assess the orthostatic challenge tests as a criteria of safety and tolerability variables.

  6. Safety assessed by laboratory tests: Hematology

    Time frame: Up to Day 38

    To assess hematology as a criteria of safety and tolerability variables.

  7. Safety assessed by laboratory tests: Biochemistry

    Time frame: Up to Day 38

    To assess biochemistry as a criteria of safety and tolerability variables.

  8. Safety assessed by laboratory tests: Urinalysis

    Time frame: Up to Day 38

    To assess urinalysis as a criteria of safety and tolerability variables.

  9. Safety assessed by 12-lead electrocardiogram

    Time frame: Up to Day 21

    To assess the cardiovascular system functioning as a criteria of safety and tolerability variables.

  10. Columbia-Suicide Severity Rating Scale

    Time frame: Up to Day 20

    To assess the suicide risk

  11. Safety assessed by body weight

    Time frame: Up to Day 38

    To assess the body weight as a criteria of safety and tolerability variables.

Secondary outcomes

  1. Pharmacokinetics (PK) parameter for ASP8062: Maximum observed concentration (Cmax)

    Time frame: Up to Day 38

    To assess the PK of ASP8062 in single dose part and multiple dose part.

  2. PK parameter for ASP8062: Time to maximum concentration (Tmax)

    Time frame: Up to Day 38

    To assess the PK of ASP8062 in single dose part and multiple dose part.

  3. PK parameter for ASP8062: Terminal elimination half-life (t1/2)

    Time frame: Up to Day 38

    To assess the PK of ASP8062 in single dose part and multiple dose part.

  4. PK parameter for ASP8062: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F)

    Time frame: Up to Day 38

    To assess the PK of ASP8062 in single dose part and multiple dose part.

  5. PK parameter for ASP8062: Area under the concentration-time curve (AUC) from the time of dosing to 24 h after dosing (AUC24)

    Time frame: Up to Day 6

    To assess the PK of ASP8062 in single dose part.

  6. PK parameter for ASP8062: AUC from the time of dosing extrapolated to time infinity (AUCinf)

    Time frame: Up to Day 6

    To assess the PK of ASP8062 in single dose part.

  7. PK parameter for ASP8062: AUC from the time of dosing to the last measurable concentration (AUClast)

    Time frame: Up to Day 6

    To assess the PK of ASP8062 in single dose part.

  8. PK parameter for ASP8062: Time point prior to the time point corresponding to the first measurable (non-zero) concentration (tlag)

    Time frame: Up to Day 6

    To assess the PK of ASP8062 in single dose part.

  9. PK parameter for ASP8062: Apparent volume of distribution during the terminal elimination phase after single extra-vascular dosing (Vz/F)

    Time frame: Up to Day 6

    To assess the PK of ASP8062 in single dose part.

  10. PK parameter for ASP8062: AUC from the time of dosing to the start of the next dosing interval (AUCtau)

    Time frame: From Day 7 to Day 38

    To assess the PK of ASP8062 in multiple dose part.

  11. PK parameter for ASP8062: Concentration immediately prior to dosing at multiple dosing (Ctrough)

    Time frame: From Day 7 to Day 20

    To assess the PK of ASP8062 in multiple dose part.

  12. PK parameter for ASP8062: Percentage of AUCinf that is estimated by extrapolation (AUCinf (%extrap))

    Time frame: Up to Day 6

    To assess the PK of ASP8062 in single dose part

  13. PK parameter for ASP8062: Terminal elimination rate constant (Lambda z)

    Time frame: Up to Day 38

    To assess the PK of ASP8062 in single dose part and multiple dose part.

  14. PK parameter for ASP8062: Time of the last measurable concentration (tlast)

    Time frame: Up to Day 38

    To assess the PK of ASP8062 in single dose part and multiple dose part.

  15. Accumulation Ratio (Rac) of Cmax

    Time frame: From Day 7 to Day 38

    To assess the PK of ASP8062 in multiple dose part.

  16. Rac of AUC

    Time frame: From Day 7 to Day 38

    To assess the PK of ASP8062 in multiple dose part.

  17. Peak-Trough Ratio for last dosing in multiple dose part

    Time frame: Day 20 and Day 21

    To assess the PK of ASP8062 in multiple dose part.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

ASP8062 Phase 1 Study - A Placebo-controlled, Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Male and Female Subjects -

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 12, 2017
Registry last updated
Oct 21, 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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