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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01396135
First received: July 14, 2011
Last updated: September 3, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: CP-601,927
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 [ Time Frame: 0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Day1-7 ] [ Designated as safety issue: No ]
  • Suicidality assessment after single dose of 1 mg CP-601,927 [ Time Frame: Day 0, 0 and 2 hours post-dose ] [ Designated as safety issue: Yes ]
  • Suicidality assessment after single dose of 2 mg CP-601,927 [ Time Frame: Day 0, 0 and 2 hours post-dose ] [ Designated as safety issue: Yes ]
  • Suicidality assessment after single dose of 3 mg CP-601,927 [ Time Frame: Day 0, 0 and 2 hours post-dose ] [ Designated as safety issue: Yes ]
  • Suicidality assessment after multiple doses of CP-601,927 given as 2 mg BID (4mg/day) for 7 days [ Time Frame: Day1-7 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 19
Study Start Date: August 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: Multiple dosing
Multiple doses of CP-601,927 (2 mg BID, 4mg/day) or placebo
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396135

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01396135     History of Changes
Other Study ID Numbers: A3331019
Study First Received: July 14, 2011
Last Updated: September 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 1
Pharmacokinetics
Healthy
Japanese
Non-smokers
Major Depressive Disorder
CP-601
927

ClinicalTrials.gov processed this record on April 22, 2014