Clinical trial NCT01396135: A Phase 1 Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-601,927 In Healthy Japanese Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
Pharmacokinetics
Healthy
Japanese
Non-smokers
Major Depressive Disorder
CP-601
927
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
measure: 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
timeFrame: 0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
measure: 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
timeFrame: 0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
measure: 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
timeFrame: Day1-7
measure: Suicidality assessment after single dose of 1 mg CP-601,927
timeFrame: Day 0, 0 and 2 hours post-dose
measure: Suicidality assessment after single dose of 2 mg CP-601,927
timeFrame: Day 0, 0 and 2 hours post-dose
measure: Suicidality assessment after single dose of 3 mg CP-601,927
timeFrame: Day 0, 0 and 2 hours post-dose
measure: Suicidality assessment after multiple doses of CP-601,927 given as 2 mg BID (4mg/day) for 7 days
timeFrame: Day1-7
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: