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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01396135

Enrollment

Registered

2011-07-18

Start date

2011-08-26

Completion date

2011-10-29

Last updated

2018-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Phase 1, Pharmacokinetics, Healthy, Japanese, Non-smokers, Major Depressive Disorder, CP-601, 927

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.

Interventions

DRUGCP-601,927

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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 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 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026