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

NCT01396135 | Withdrawn Phase 1

• 1 other identifier: A3331019
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Single dosing

EXPERIMENTAL

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

Drug: CP-601,927; Drug: Placebo

Multiple dosing

EXPERIMENTAL

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

Drug: CP-601,927; Drug: Placebo

Interventions

CP-601,927 DRUG

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

Single dosing

Placebo DRUG

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

Single dosing

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 18, 2011
• Study Start: August 26, 2011
• Primary Completion: October 29, 2011
• Study Completion: October 29, 2011
• Last Updated: October 30, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share