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

NCT ID: NCT01387087

Last Updated: 2011-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2008-11-30

Brief Summary

The objective of the study is to explore safety and tolerability of single ascending doses of ASP015K, establish the maximum tolerated dose, and determine the pharmacokinetics and pharmacodynamics in healthy volunteers.

Detailed Description

Subjects will be confined to the clinical research unit for five days. Some subjects will participate in two confinement periods. Subjects will receive a follow-up phone call to assess safety seven days after the administration of the single dose of study drug.

Subjects will be assigned to one of nine sequential groups A, B, C, D, E, F, G, H, or I. In each group, 6 subjects will be randomized to ASP015K and 2 subjects will be randomized to placebo. Subjects in group F will participate in two treatment periods. Subjects in the first treatment period of group F will have a single study drug dose administered in the fasted state. Subjects in the second treatment period of group F will have a single study drug dose administered immediately following a standard FDA recommended high-fat breakfast.

Conditions

Healthy Subjects; Pharmacokinetics of ASP015K

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

Lowest dose, all males, fasting

Group Type: EXPERIMENTAL

ASP015K

Intervention Type: DRUG

oral

Group B

Second lowest dose, all males, fasting

Group Type: EXPERIMENTAL

ASP015K

Intervention Type: DRUG

oral

Group C

Third lowest dose, all males, fasting

Group Type: EXPERIMENTAL

ASP015K

Intervention Type: DRUG

oral

Group D

Middle dose, all males, fasting

Group Type: EXPERIMENTAL

ASP015K

Intervention Type: DRUG

oral

Group E

Third lowest dose, all females, fasting

Group Type: EXPERIMENTAL

ASP015K

Intervention Type: DRUG

oral

Group F

Third highest dose, all males, fasting then fed

Group Type: EXPERIMENTAL

ASP015K

Intervention Type: DRUG

oral

Group G

Second highest dose, all males, fasting

Group Type: EXPERIMENTAL

ASP015K

Intervention Type: DRUG

oral

Group H

Highest dose, all males, fasting

Group Type: EXPERIMENTAL

ASP015K

Intervention Type: DRUG

oral

Group I

Second highest dose, all females, fasting

Group Type: EXPERIMENTAL

ASP015K

Intervention Type: DRUG

oral

Placebo Group A

all male, fasting

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral

Placebo Group B

all male, fasting then fed

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral

Placebo Group C

all female, fasting

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral

Interventions

ASP015K

oral

Intervention Type: DRUG

Placebo

oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 and has not used tobacco for a minimum of 3 months
• Subjects must weigh at least 45 kg and have a Body Mass Index (BMI) of 18-32 kg/m2

Exclusion Criteria

• Subject has a positive test for hepatitis C antibody, or positive for hepatitis B surface antigen (HBsAg)
• Subject has a history of the 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 history of drug or alcohol abuse or a positive urine screen for alcohol or drugs of abuse and/or illegal drugs
• 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

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

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Astellas Pharma Global Developmnt

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

Clinical Pharmacology of Miami

Miami, Florida, United States

Prism Research

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

015K-CL-HV01

Identifier Type: -

Identifier Source: org_study_id