Pharmacokinetics, Safety and Tolerability Study of PF-03463275 in Healthy Male Japanese and Western Subjects

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01159626
First received: July 8, 2010
Last updated: April 19, 2011
Last verified: April 2011
  Purpose

This Phase 1 study is the first clinical trial in Japanese subjects. The study is designed to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of PF-03463275 oral controlled release formulation in Japanese and Western male subjects.


Condition Intervention Phase
Healthy
Drug: PF-03463275
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Subject- and Investigator-blind, Sponsor-open, Placebo-controlled, Single- and Multiple-dose Escalation Study to Investigate the Pharmacokinetics, Safety and Tolerability of PF-03463275 in Healthy Male Japanese and Western Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Adverse events monitoring [ Time Frame: Day 0 to Day 4 in each period of Cohort A, Day 0 to Day 10 in Cohort B ] [ Designated as safety issue: Yes ]
  • Vital signs, ECGs, clinical laboratory tests, clinical evaluations and examinations, suicidality assessment [ Time Frame: Screening and Day 0 to Day 4 in each period of Cohort A, Screening and Day 0 to Day 10 in Cohort B ] [ Designated as safety issue: Yes ]
  • Serum (after single dose): Cmax, AUClast, AUCtau (Calculated only in Cohort B) and as data permit Tmax, AUCinf, t1/2 [ Time Frame: Day 1 to Day 4 in each period of Cohort A, Day 1 in Cohort B ] [ Designated as safety issue: No ]
  • Serum (after multiple dose): Ctrough, Cmax*, AUCtau* and as data permit Tmax*, t1/2* and Rac* (accumulation ratio) * Calculated only after the last administration. [ Time Frame: Day 2 to Day 10 in Cohort B ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: July 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single dose Drug: PF-03463275
Oral single 20 mg dose as two 10mg controlled release tablets
Drug: PF-03463275
Oral single 40 mg dose as four 10mg controlled release tablets
Drug: PF-03463275
Oral single 60 mg dose as six 10mg controlled release tablets
Other Name: Not Specified
Drug: Placebo
Oral single dose as matching placebo
Experimental: Multiple dose Drug: PF-03463275
Oral multiple 40 mg doses as four 10mg controlled release tablets for 7 days
Other Name: Not Specified
Drug: Placebo
Oral multiple doses as matching placebo for 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects between the ages of 18 and 55 years.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2, and a total body weight >50 kg (110 lbs).
  • Japanese subjects must have four Japanese grandparents who were born in Japan.

Exclusion Criteria:

  • Subjects that are genotyped to be PM (poor metabolizer), UM (ultrarapid metabolizer), IM/EM and EM/UM for CYP2D6 status.
  • Evidence or history of clinically significant hematological (including anemia), renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159626

Locations
United States, California
Pfizer Investigational Site
Glendale, California, United States, 91206
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01159626     History of Changes
Other Study ID Numbers: A9131010
Study First Received: July 8, 2010
Last Updated: April 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase1
Pharmacokinetics
Healthy Male
Japanese
Schizophrenia

ClinicalTrials.gov processed this record on October 20, 2014