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

NCT02141425 | Completed Phase 1

• 1 other identifier: 015K-CL-HV07
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers; Pharmacokinetics of ASP015K

Keywords

Healthy volunteers; ASP015K

Outcome Measures

Primary Outcomes (1)

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

  Days 1-4

Secondary Outcomes (2)

• Pharmacokinetic profile of ASP015K: Cmax, AUClast, AUCinf, tmax, t1/2, CL/F, Vz/F

  Days 1-4

• Pharmacokinetic profile of ASP015K metabolites: Cmax, AUClast, AUCinf, tmax, t1/2

  Days 1-4

Study Arms (4)

ASP015K low dose

EXPERIMENTAL

Drug: ASP015K

ASP015K medium dose

EXPERIMENTAL

Drug: ASP015K

ASP015K high dose

EXPERIMENTAL

Optional, depending on safety review and regulatory authority input

Drug: ASP015K

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ASP015K DRUG

oral

ASP015K high dose; ASP015K low dose; ASP015K medium dose

Placebo DRUG

oral

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 -1.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead
• Janssen Biotech, Inc.: collaborator

Study Sites (1)

California Clinical Trials Medical Group/Parexel

Glendale, California, 91206, United States

Location

MeSH Terms

Interventions

peficitinib

Study Officials

• Senior Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 19, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 4, 2014

Record last verified: 2014-06

Locations

US (1)