A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K in Healthy Subjects

NCT ID: NCT02141425

Last Updated: 2014-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-04-30

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.

Conditions

Healthy Volunteers; Pharmacokinetics of ASP015K

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

ASP015K low dose

Group Type: EXPERIMENTAL

ASP015K

Intervention Type: DRUG

oral

ASP015K medium dose

Group Type: EXPERIMENTAL

ASP015K

Intervention Type: DRUG

oral

ASP015K high dose

Optional, depending on safety review and regulatory authority input

Group Type: EXPERIMENTAL

ASP015K

Intervention Type: DRUG

oral

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral

Interventions

ASP015K

oral

Intervention Type: DRUG

Placebo

oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female subject must be either:

• Of non-childbearing potential:

1. postmenopausal (defined as at least 1 year without any menses) prior to screening,

2. or documented surgically sterile or status post-hysterectomy (at least 1 month prior to screening).

• Or, if of childbearing potential:

1. must have a negative pregnancy test at screening and day -1.

2. 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.
• Subject has a Body Mass Index (BMI) range of 18.5 to 32.0 kg/m2, inclusive, and must weigh at least 50 kg at screening.
• Subject must be capable of swallowing multiple (up to 20) tablets.
• Subject agrees not to participate in another investigational study while on treatment.

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 -1. If the result is outside the limits, the assessment may be repeated once at screening and day -1.
• 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 -1.
• 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 -1.
• 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 -1.
• Subject has a mean QTcF interval of > 430 msec (for males) and > 450 msec (for females) at screening or day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG can be taken. If this triplicate also gives an abnormal result, the subject should be excluded.
• Subject has used any prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to study drug administration, with the exception of hormone replacement therapy (HRT), hormonal contraceptives and intermittent acetaminophen (no more than 2g per day).
• Subject has smoked or has used tobacco-containing products and nicotine or nicotine-containing products in the past 6 months prior to screening.
• Subject has a history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical substance abuse within the past 2 years prior to screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits).
• Subject has a positive test for alcohol, drugs of abuse or cotinine at screening or day -1.
• Subject anticipates an inability to abstain from xanthine (e.g., caffeine), grapefruit, Seville oranges (including marmalade), star fruit or any products containing these items from 72 hours prior to day -1 and throughout the duration of the study.
• Subject has used any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to day -1.
• Subject has had any significant blood loss, donated 1 unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to day -1.
• Subject has a positive test for hepatitis B surface antigen, anti-hepatitis A virus (Immunoglobulin M) antibody, anti-hepatitis C virus antibody, hepatitis B core antibody or anti-human immunodeficiency virus Type 1 or Type 2 at screening.
• Subject has a positive tuberculosis skin test, Quantiferon Gold® or T-SPOT® test at screening.
• Subject has received any vaccine within 60 days prior to study drug administration.
• Subject has an absolute neutrophil count (ANC) < 2000 cells/mm3 or a creatine phosphokinase (CPK) > 1.5 x ULN at screening or day -1. If the result is outside the limits, the assessment may be repeated once at screening and day -1.
• Subject has had major GI surgery or has a medical condition that may inhibit the absorption and/or metabolism of study drug.
• Subject has participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half-lives of the drug, whichever is longer, prior to screening.
• Subject has any other condition, which in the opinion of the investigator, precludes the subject's participation in the study.
• Subject is an employee of the Astellas Group, Janssen Pharmaceuticals or vendors involved in the study.
• Subject has participated in a prior study with ASP015K.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Biotech, Inc.

INDUSTRY

Sponsor Role: collaborator

Astellas Pharma Global Development, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Senior Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Global Development, Inc.

Locations

California Clinical Trials Medical Group/Parexel

Glendale, California, United States

Countries

United States

Other Identifiers

015K-CL-HV07

Identifier Type: -

Identifier Source: org_study_id