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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This study has been withdrawn prior to enrollment.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
History of Changes

July 14, 2011
September 3, 2011
August 2011
October 2011   (final data collection date for primary outcome 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 [ 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 ]
Same as current
Complete list of historical versions of study NCT01396135 on ClinicalTrials.gov Archive Site
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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

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
19
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01396135
A3331019
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2011

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