A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP015K Following Single Doses in Healthy Subjects

Astellas Pharma Global Development, Inc.1 site in 1 country16 target enrollmentMarch 2014

ConditionsHealthy Volunteers Pharmacokinetics of ASP015K

InterventionsASP015K Placebo

DrugsASP015K Placebo

Overview

Phase: Phase 1
Intervention: ASP015K
Conditions: Healthy Volunteers
Sponsor: Astellas Pharma Global Development, Inc.
Enrollment: 16
Locations: 1
Primary Endpoint: Safety as assessed by adverse events, clinical laboratory tests, electrocardiogram (ECG) measurements, physical examination abnormalities and vital signs
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single ascending doses of ASP015K.

Detailed Description

Subjects will be enrolled in 1 of 3 dose cohorts (low, medium and high). Each cohort will consist of 8 subjects with a 3:1 randomization ratio for ASP015K to placebo. Subjects will be confined to the clinic for study procedures until day 4 (5 days). After all subjects in a dose cohort have completed study procedures through day 4, a decision will be made whether or not dosing and enrollment of the next dose cohort should occur, which will only take place after a review of the safety and tolerability data through day 4 of the most recent dose cohort and any additional reported adverse events (AEs) for previously dosed cohorts.

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

April 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Astellas Pharma Global Development, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female subject must be either:
•Of non-childbearing potential:
•postmenopausal (defined as at least 1 year without any menses) prior to screening,
•or documented surgically sterile or status post-hysterectomy (at least 1 month prior to screening).
•Or, if of childbearing potential:
•must have a negative pregnancy test at screening and day -
•must use highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and throughout the study period and for 90 days after final study drug administration.
•Female subject must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration.
•Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continuing throughout the study period, and for 90 days after final study drug administration.
•Male subject must not donate sperm starting at screening and continuing throughout the study period, and for 90 days after final study drug administration.

Exclusion Criteria

•Female subject who has been pregnant within 6 months before screening assessment or breast feeding within 3 months before screening.
•Subject has a known or suspected hypersensitivity to ASP015K or any components of the formulations used.
•Subject has any of the liver function tests (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase or total bilirubin) above the ULN at screening or day -
•If the result is outside the limits, the assessment may be repeated once at screening and day -
•Subject has any clinically significant history of allergic conditions.
•Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal (GI), endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, as judged by the investigator or designee.
•Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (non-cutaneous) infection within 1 week prior to day -
•Subject has any clinically significant abnormality following the investigator's review of the physical examination, electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or day -
•Subject has a mean pulse \< 40 or \> 90 beats per minute, mean systolic blood pressure (BP) \> 140 mmHg or mean diastolic BP \> 90 mmHg (measurements taken in triplicate after subject has been resting in sitting position for 5 minutes) at screening or day -
•Subject has a mean QTcF interval of \> 430 msec (for males) and \> 450 msec (for females) at screening or day -

Arms & Interventions

ASP015K low dose

Intervention: ASP015K

ASP015K medium dose

Intervention: ASP015K

ASP015K high dose

Optional, depending on safety review and regulatory authority input

Intervention: ASP015K

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Safety as assessed by adverse events, clinical laboratory tests, electrocardiogram (ECG) measurements, physical examination abnormalities and vital signs

Time Frame: Days 1-4

Secondary Outcomes

Pharmacokinetic profile of ASP015K metabolites: Cmax, AUClast, AUCinf, tmax, t1/2(Days 1-4)
Pharmacokinetic profile of ASP015K: Cmax, AUClast, AUCinf, tmax, t1/2, CL/F, Vz/F(Days 1-4)