PK And Safety Study Of PF-04171327 In Healthy Japanese And Western Subjects In Fasting And Fed Conditions
- Registration Number
- NCT01362673
- Lead Sponsor
- Pfizer
- Brief Summary
This Phase 1 study is the first clinical trial in Japanese subjects. This study is designed to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of PF-04171327 oral tablet in healthy adult Japanese and Western subjects in fasting and fed conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
- Healthy male and/or female subjects of non childbearing potential 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 >45 kg (99 lbs).
- Japanese subjects who have four Japanese grandparents born in Japan.
Exclusion Criteria
- Confirmed fasting glucose more than 100 mg/dL at Screening and Day 0 in both Cohort A and B.
- Corticosteroid use of more than 5 mg prednisone equivalent per day for more than 6 weeks.
- 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 the time of dosing).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Single dose PF-04171327 - Single dose Placebo - Multiple dose PF-04171327 - Multiple dose Placebo -
- Primary Outcome Measures
Name Time Method Plasma pharmacokinetic parameters for PF-00251802: Cmax for Day 1 and Day 12 Day 1 to Day 15 in Cohort B Plasma pharmacokinetic parameters for PF-00251802 : Cmax Day 1 to Day 4 in each period of Cohort A Plasma pharmacokinetic parameters for PF-00251802 : Tmax Day 1 to Day 4 in each period of Cohort A Plasma pharmacokinetic parameters for PF00251802 : AUC(0-last) Day 1 to Day 4 in each period of Cohort A Plasma pharmacokinetic parameters for PF-00251802 : As data permit AUC(0-inf) Day 1 to Day 4 in each period of Cohort A Plasma pharmacokinetic parameters for PF-00251802 : As data permit t1/2 Day 1 to Day 4 in each period of Cohort A Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Cmax Day 1 to Day 4 in each period of Cohort A Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Tmax Day 1 to Day 4 in each period of Cohort A Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): AUC(0-last) Day 1 to Day 4 in each period of Cohort A Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit AUC(0-inf) Day 1 to Day 4 in each period of Cohort A Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit t1/2 Day 1 to Day 4 in each period of Cohort A Plasma pharmacokinetic parameters for PF-00251802: Tmax for Day 1 and Day 12 Day 1 to Day 15 in Cohort B Plasma pharmacokinetic parameters for PF-00251802: AUCtau for Day 1 and Day 12 Day 1 to Day 15 in Cohort B Plasma pharmacokinetic parameters for PF-00251802: As data permit t1/2 for Day12 Day 1 to Day 15 in Cohort B Plasma pharmacokinetic parameters for PF-00251802: As data permit Rac (accumulation ratio = Day 12 AUCtau/Day 1 AUCtau) for Day12 Day 1 to Day 15 in Cohort B Plasma pharmacokinetic parameters for PF-00251802: Ctrough Day 1 to Day 15 in Cohort B Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Cmax for Day 1 and Day 12 Day 1 to Day 15 in Cohort B Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Tmax for Day 1 and Day 12 Day 1 to Day 15 in Cohort B Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): AUCtau for Day 1 and Day 12 Day 1 to Day 15 in Cohort B Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit t1/2 for Day12 Day 1 to Day 15 in Cohort B Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit Rac (accumulation ratio = Day 12 AUCtau/Day 1 AUCtau) for Day12 Day 1 to Day 15 in Cohort B Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Ctrough Day 1 to Day 15 in Cohort B
- Secondary Outcome Measures
Name Time Method Biomarkers for bone effects: Serum procollagen type 1 N-terminal propeptide (P1NP), serum C terminal telopeptide of type I collagen (CTX), serum osteocalcin and urine N terminal telopeptide of type I collagen (uNTX). Day 0 to Day 15 in Cohort B Biomarkers for carbohydrate and metabolic: Plasma cortisol, serum glucose, plasma insulin and serum adiponectin. Day 0 to Day 15 in Cohort B
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Glendale, California, United States