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Completed

NCT Number: NCT02796118

Study to Evaluate the Safety and Pharmacokinetics of ASP2151 in Healthy Non-elderly and Elderly Subjects

The objective of this study is to evaluate the safety and the pharmacokinetics of ASP2151 after multiple oral dosing of ASP2151 in healthy non-elderly male and elderly male Japanese subjects, and to compare the pharmacokinetics of ASP2151 in healthy non-elderly male and elderly male Japanese subjects.

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Key information

Conditions

Healthy Subjects

Age range

20 year–79 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Site JP00001

Osaka, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body weight: ≥50.0 kg and <85.0 kg
  • Body mass index (BMI): ≥17.6 and <26.4 kg/m2

Exclusion criteria

  • Subjects with a complication of any diseases
  • Subjects with a history of hepatic disease
  • Subjects with a history of heart disease
  • Subjects with a history of respiratory disease
  • Subjects with a history of alimentary disease
  • Subjects with a history of renal disease
  • Subjects with a history of cerebrovascular disorder
  • Subjects with a history of malignant tumor
  • Subjects with a history of drug allergies or allergies disorders excluding pollinosis
  • Subjects with a history of drug dependency or alcohol dependence syndrome
  • Subjects who developed genital herpes or herpes zoster within 90 days before the initial dosing
  • Subjects who do not meet any of the criteria for laboratory tests
  • Subjects who received medications within 14 days before the initial dosing.
  • Subjects who received any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening or the initial dosing
  • Excessive alcohol drinking or smoking habit
  • Subjects who previously received administration of ASP2151 (including placebo)
  • Abnormalities detected on an ophthalmological examination
  • Subjects who deviate from the normal range of standard 12-lead ECG at screening

Treatment and study plan

ASP2151

Drug

Oral

Placebo

Drug

Oral

Primary outcomes

  1. Pharmacokinetics of ASP2151 in plasma: Cmax

    Time frame: Up to Day 9

    Cmax: Maximum concentration

  2. Pharmacokinetics of ASP2151 in plasma: tmax

    Time frame: Up to Day 9

    tmax: The time after dosing when Cmax occurs

  3. Pharmacokinetics of ASP2151 in plasma: t1/2

    Time frame: Up to Day 9

    t1/2: Apparent terminal elimination half-life

  4. Pharmacokinetics of ASP2151 in plasma: C24

    Time frame: Up to Day 9

    C24: Concentration at 24hours after dosing

  5. Pharmacokinetics of ASP2151 in plasma: AUC24

    Time frame: Up to Day 9

    AUC24: Area under the concentration-time curve from the time of dosing to 24hours after dosing

  6. Pharmacokinetics of ASP2151 in plasma: AUCinf

    Time frame: Up to Day 9

    AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity

  7. Pharmacokinetics of ASP2151 in plasma: CL/F

    Time frame: Up to Day 9

    CL/F: Apparent total systemic clearance

  8. Pharmacokinetics of ASP2151 in urine: Ae

    Time frame: Up to Day 9

    Ae: Amount excreted in urine

  9. Pharmacokinetics of ASP2151 in urine: Cumulative Ae

    Time frame: Up to Day 9

  10. Pharmacokinetics of ASP2151 in urine: Ae%

    Time frame: Up to Day 9

    Ae%: Percent of ASP2151 amount excreted in urine

  11. Pharmacokinetics of ASP2151 in urine: Cumulative Ae%

    Time frame: Up to Day 9

  12. Pharmacokinetics of ASP2151 in urine: CLR

    Time frame: Up to Day 9

    CLR: Renal clearance

  13. Safety assessed by laboratory test: Hematology

    Time frame: Up to Day 14

  14. Safety assessed by laboratory test: blood biochemistry

    Time frame: Up to Day 14

  15. Safety assessed by laboratory test: urinalysis

    Time frame: Up to Day 14

  16. Safety assessed by Vital sign measurement: axillary body temperature

    Time frame: Up to Day 14

  17. Safety assessed by vital sign measurement: supine blood pressure

    Time frame: Up to Day 14

  18. Safety assessed by vital sign measurement: supine pulse rate

    Time frame: Up to Day 14

  19. Safety assessed by Standard 12-lead electrocardiogram

    Time frame: Up to Day 14

  20. Safety assessed by Standard 12-lead electrocardiogram for QT assessment

    Time frame: Up to Day 14

  21. Safety assessed by ophthalmological examination

    Time frame: Up to Day 14

  22. Safety assessed by incidence of adverse events

    Time frame: Up to Day 14

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

ASP2151 Phase 1 Study - Multiple Oral Dosing Study in Healthy Non-elderly Male and Elderly Male Japanese Subjects-

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jun 10, 2016
Registry last updated
Aug 29, 2016

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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