A Phase 1 Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-601,927 In Healthy Japanese Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-26

Study Completion Date

2011-10-29

Brief Summary

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This Phase 1 study is the first clinical trial to be conducted in Japanese subjects. The pharmacokinetics, safety and tolerability of single and multiple doses of CP-601,927 will be evaluated in Japanese, healthy, non-smoking subjects.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Single dosing

Single doses of CP-601,927 (1, 2 or 3 mg) or placebo

Group Type EXPERIMENTAL

CP-601,927

Intervention Type DRUG

Single dose of 1 mg CP-601,927 given as oral 1 mg tablets

CP-601,927

Intervention Type DRUG

Single dose of 2 mg CP-601,927 given as oral 1 mg tablets

CP-601,927

Intervention Type DRUG

Single dose of 3 mg CP-601,927 given as oral 1 mg tablets

Placebo

Intervention Type DRUG

Single dose of placebo given as a matching number of oral tablets

Multiple dosing

Multiple doses of CP-601,927 (2 mg BID, 4mg/day) or placebo

Group Type EXPERIMENTAL

CP-601,927

Intervention Type DRUG

Multiple doses of CP-601,927 given as 2 mg BID (4 mg/day) as oral 1 mg tablets for 7 days

Placebo

Intervention Type DRUG

Multiple doses of placebo given as a matching number of oral tablets

Interventions

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CP-601,927

Single dose of 1 mg CP-601,927 given as oral 1 mg tablets

Intervention Type DRUG

CP-601,927

Single dose of 2 mg CP-601,927 given as oral 1 mg tablets

Intervention Type DRUG

CP-601,927

Single dose of 3 mg CP-601,927 given as oral 1 mg tablets

Intervention Type DRUG

Placebo

Single dose of placebo given as a matching number of oral tablets

Intervention Type DRUG

CP-601,927

Multiple doses of CP-601,927 given as 2 mg BID (4 mg/day) as oral 1 mg tablets for 7 days

Intervention Type DRUG

Placebo

Multiple doses of placebo given as a matching number of oral tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female Japanese subjects between the ages of 18 and 55 years, inclusive.
* Japanese defined as being able to document that all 4 grandparents were Japanese and were born in Japan.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Females of childbearing potential.
* Subjects with regular (daily or weekly) use of tobacco products or nicotine currently or within the past 6 months. Subjects with urine cotinine concentrations \>100 ng/mL at any time during the study will be excluded.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes