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

NCT01159626 | Completed Phase 1

• 1 other identifier: A9131010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Phase1; Pharmacokinetics; Healthy Male; Japanese; Schizophrenia

Outcome Measures

Primary Outcomes (4)

• Adverse events monitoring

  Day 0 to Day 4 in each period of Cohort A, Day 0 to Day 10 in Cohort B

• Vital signs, ECGs, clinical laboratory tests, clinical evaluations and examinations, suicidality assessment

  Screening and Day 0 to Day 4 in each period of Cohort A, Screening and Day 0 to Day 10 in Cohort B

• Serum (after single dose): Cmax, AUClast, AUCtau (Calculated only in Cohort B) and as data permit Tmax, AUCinf, t1/2

  Day 1 to Day 4 in each period of Cohort A, Day 1 in Cohort B

• Serum (after multiple dose): Ctrough, Cmax*, AUCtau* and as data permit Tmax*, t1/2* and Rac* (accumulation ratio) * Calculated only after the last administration.

  Day 2 to Day 10 in Cohort B

Study Arms (2)

Single dose

EXPERIMENTAL

Drug: PF-03463275; Drug: Placebo

Multiple dose

EXPERIMENTAL

Drug: PF-03463275; Drug: Placebo

Interventions

PF-03463275 DRUG

Oral single 20 mg dose as two 10mg controlled release tablets

Single dose

Placebo DRUG

Oral single dose as matching placebo

Single dose

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Glendale, California, 91206, United States

Location

Related Links

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

MeSH Terms

Conditions

Schizophrenia

Interventions

1-methyl-1H-imidazole-4-carboxylic acid (3-chloro-4-fluoro-benzyl)-(3-methyl-3-aza-bicyclo(3.1.0) hex-6-ylmethyl)amide

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic 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: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 9, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: April 20, 2011

Record last verified: 2011-04

Locations

US (1)