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

A Phase 1, Randomized, Subject- And Investigator-blind, Sponsor-open, Placebo-controlled, Single- And Multiple-dose Study To Investigate The Pharmacokinetics, Safety And Tolerability Of Cp-601,927 In Healthy Japanese Subjects

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy
• Intervention / Treatment: Drug: CP-601,927; Drug: CP-601,927; Drug: CP-601,927; Drug: Placebo; Drug: CP-601,927; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single dosing; Single doses of CP-601,927 (1, 2 or 3 mg) or placebo	Drug: CP-601,927; Single dose of 1 mg CP-601,927 given as oral 1 mg tablets; Drug: CP-601,927; Single dose of 2 mg CP-601,927 given as oral 1 mg tablets; Drug: CP-601,927; Single dose of 3 mg CP-601,927 given as oral 1 mg tablets; Drug: Placebo; Single dose of placebo given as a matching number of oral tablets; 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; Drug: Placebo; Multiple doses of placebo given as a matching number of oral tablets
Experimental: Multiple dosing; Multiple doses of CP-601,927 (2 mg BID, 4mg/day) or placebo	Drug: CP-601,927; Single dose of 1 mg CP-601,927 given as oral 1 mg tablets; Drug: CP-601,927; Single dose of 2 mg CP-601,927 given as oral 1 mg tablets; Drug: CP-601,927; Single dose of 3 mg CP-601,927 given as oral 1 mg tablets; Drug: Placebo; Single dose of placebo given as a matching number of oral tablets; 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; Drug: Placebo; Multiple doses of placebo given as a matching number of oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 1 mg CP-601,927	Day 0, 0 and 2 hours post-dose
Suicidality assessment after single dose of 2 mg CP-601,927	Day 0, 0 and 2 hours post-dose
Suicidality assessment after single dose of 3 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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2011
• Primary Completion (Anticipated): October 29, 2011
• Study Completion (Anticipated): October 29, 2011

Study Registration Dates

• First Submitted: July 14, 2011
• First Submitted That Met QC Criteria: July 14, 2011
• First Posted (Estimate): July 18, 2011

Study Record Updates

• Last Update Posted (Actual): October 30, 2018
• Last Update Submitted That Met QC Criteria: October 27, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Healthy; Pharmacokinetics; Japanese; Phase 1; Major Depressive Disorder; Non-smokers; CP-601; 927
• Other Study ID Numbers: A3331019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests