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

Pfizer

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: CP-601,927

Study type: Interventional

Funder types: Industry

Identifiers

NCT01396135

A3331019

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Single dosing

Experimental group

Description:

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

Treatment:

Drug: CP-601,927

Drug: CP-601,927

Drug: CP-601,927

Drug: Placebo

Drug: Placebo

Drug: CP-601,927

Multiple dosing

Experimental group

Description:

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

Treatment:

Drug: CP-601,927

Drug: CP-601,927

Drug: CP-601,927

Drug: Placebo

Drug: Placebo

Drug: CP-601,927