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

NCT01364974 | Completed Phase 1

• 1 other identifier: 015K-CL-HV02
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to explore safety and tolerability of multiple oral doses of ASP015K in healthy volunteers.

Conditions

Healthy Subjects; Pharmacokinetics of ASP015K; Pharmacodynamics

Keywords

ASP015K; Healthy subjects

Outcome Measures

Primary Outcomes (3)

• Safety and tolerability assessed through vital signs, electrocardiograms (ECGs), physical exams, reports of adverse events, and analysis of blood and urine samples

  25 days

• Pharmacokinetic assessment through the analysis of blood and urine samples

  17 days

• Pharmacodynamic assessment through the analysis of blood samples

  17 days

Study Arms (5)

Group A

EXPERIMENTAL

low dose, all male

Drug: ASP015K; Drug: Placebo

Group B

EXPERIMENTAL

medium dose, all male

Drug: ASP015K; Drug: Placebo

Group C

EXPERIMENTAL

high dose, all male

Drug: ASP015K; Drug: Placebo

Group D

EXPERIMENTAL

medium dose, all female

Drug: ASP015K; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ASP015K DRUG

oral

Group A; Group B; Group C; Group D

Placebo DRUG

oral

Group A; Group B; Group C; Group D; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• If female, the subject is at least 2 years post menopausal or is surgically sterile per documentation provided by a third party medical professional and the subject is not pregnant as documented by a negative serum pregnancy test
• If male, the subject agrees to sexual abstinence and/or to use a highly effective method of birth control during the study period
• Subject is medically healthy, with no clinically significant abnormalities on medical history or abnormalities observed upon physical examination or 12 lead electrocardiogram (ECG)
• Subject's fasting clinical laboratory values are within normal limits
• Subject is a non-smoker or a light smoker (\< 10 cigarettes/day)
• Subjects must weigh at least 45 kg and have a Body Mass Index (BMI) of 18-32 kg/m2

You may not qualify if:

• Subject has a positive test for hepatitis C antibody, or positive for hepatitis B surface antigen (HBsAg)
• Subject is known positive for human immunodeficiency virus (HIV) antibody
• Subject has a history of severe allergic or anaphylactic reactions
• Subject has a history of chronic diarrhea
• Subject has been vaccinated within the last 60 days prior to study drug administration
• Subject has a previous history of any clinically significant neurological, gastrointestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the Investigator's opinion, would preclude participation in the study
• Subject has had clinically significant illness within 1 month prior to study drug administration
• Subject has a history of hemorrhoids
• Subject has a positive guaiac test
• Subject has a history of drug or alcohol abuse, a positive urine or serum screen for drugs of abuse/illegal drugs, or positive blood or breathalyzer for alcohol
• Subject has had treatment with prescription medication (except hormone replacement therapy and acetaminophen), complementary and alternative medicines (CAM) within 14 days, over-the-counter products within 1 week, or alcohol, caffeine or grapefruit juice within 24 hours prior to study drug administration
• Subject has had treatment with another investigational drug or approved therapy for investigational use within 30 days or 10 half-lives, whichever is longer, prior to study drug administration or has participated in a prior group in the current study
• Subject has a history of blood donation within 30 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Interventions

peficitinib

Study Officials

• Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 3, 2011
• Study Start: January 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 3, 2011

Record last verified: 2011-05

Locations

US (1)