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

Phase 1

Withdrawn

• Conditions: Healthy
• Interventions: Drug: CP-601,927; Drug: Placebo

• Registration Number: NCT01396135
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-14
• Study First Posted: 2011-07-18
• Study Start: 2011-08-26
• Primary Completion: 2011-10-29
• Study Completion: 2011-10-29
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-27
• Last Update Posted: 2018-10-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single dosing	CP-601,927	Single doses of CP-601,927 (1, 2 or 3 mg) or placebo
Single dosing	Placebo	Single doses of CP-601,927 (1, 2 or 3 mg) or placebo
Multiple dosing	CP-601,927	Multiple doses of CP-601,927 (2 mg BID, 4mg/day) or placebo
Multiple dosing	Placebo	Multiple doses of CP-601,927 (2 mg BID, 4mg/day) or placebo

Primary Outcome Measures

Name	Time	Method
Suicidality assessment after single dose of 3 mg CP-601,927	Day 0, 0 and 2 hours post-dose
Suicidality assessment after single dose of 1 mg CP-601,927	Day 0, 0 and 2 hours post-dose
Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 1 mg CP-601,927	0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 2 mg CP-601,927	0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 3 mg CP-601,927	0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Ctrough, Cmax, AUC0-12, Tmax and as data permit t1/2, CL/F and Rac (accumulation ratio) based on Cmax and AUC0-12 after multiple doses of CP-601,927 given as 2 mg BID (4mg/day) for 7 days	Day1-7
Suicidality assessment after single dose of 2 mg CP-601,927	Day 0, 0 and 2 hours post-dose
Suicidality assessment after multiple doses of CP-601,927 given as 2 mg BID (4mg/day) for 7 days	Day1-7