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Trial record 1 of 1 for:    NCT01396135
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A Phase 1 Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-601,927 In Healthy Japanese Subjects

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ClinicalTrials.gov Identifier: NCT01396135
Recruitment Status : Withdrawn
First Posted : July 18, 2011
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 14, 2011
First Posted Date  ICMJE July 18, 2011
Last Update Posted Date October 30, 2018
Actual Study Start Date  ICMJE August 26, 2011
Estimated Primary Completion Date October 29, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2011)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Suicidality assessment after single dose of 1 mg CP-601,927 [ Time Frame: Day 0, 0 and 2 hours post-dose ]
  • Suicidality assessment after single dose of 2 mg CP-601,927 [ Time Frame: Day 0, 0 and 2 hours post-dose ]
  • Suicidality assessment after single dose of 3 mg CP-601,927 [ Time Frame: 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 [ Time Frame: Day1-7 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01396135 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-601,927 In Healthy Japanese Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Single dosing
    Single doses of CP-601,927 (1, 2 or 3 mg) or placebo
    Interventions:
    • Drug: CP-601,927
    • Drug: CP-601,927
    • Drug: CP-601,927
    • Drug: Placebo
  • Experimental: Multiple dosing
    Multiple doses of CP-601,927 (2 mg BID, 4mg/day) or placebo
    Interventions:
    • Drug: CP-601,927
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 27, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2011)
19
Estimated Study Completion Date  ICMJE October 29, 2011
Estimated Primary Completion Date October 29, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01396135
Other Study ID Numbers  ICMJE A3331019
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP