Clinical trial NCT01362673: PK And Safety Study Of PF-04171327 In Healthy Japanese And Western Subjects In Fasting And Fed Conditions
Official title: A Phase 1, Randomized, Subject- And Investigator Blind, Sponsor Open, Placebo Controlled, Single- And Multiple-Dose Escalation Study Of PF-04171327 In Healthy Adult Japanese And Western Subjects In Fasting And Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
Pharmacokinetics
food effect
Healthy Japanese
rheumatoid arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-05-30
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Plasma pharmacokinetic parameters for PF-00251802 : Cmax
timeFrame: Day 1 to Day 4 in each period of Cohort A
measure: Plasma pharmacokinetic parameters for PF-00251802 : Tmax
timeFrame: Day 1 to Day 4 in each period of Cohort A
measure: Plasma pharmacokinetic parameters for PF00251802 : AUC(0-last)
timeFrame: Day 1 to Day 4 in each period of Cohort A
measure: Plasma pharmacokinetic parameters for PF-00251802 : As data permit AUC(0-inf)
timeFrame: Day 1 to Day 4 in each period of Cohort A
measure: Plasma pharmacokinetic parameters for PF-00251802 : As data permit t1/2
timeFrame: Day 1 to Day 4 in each period of Cohort A
measure: Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Cmax
timeFrame: Day 1 to Day 4 in each period of Cohort A
measure: Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Tmax
timeFrame: Day 1 to Day 4 in each period of Cohort A
measure: Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): AUC(0-last)
timeFrame: Day 1 to Day 4 in each period of Cohort A
measure: Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit AUC(0-inf)
timeFrame: Day 1 to Day 4 in each period of Cohort A
measure: Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit t1/2
timeFrame: Day 1 to Day 4 in each period of Cohort A
measure: Plasma pharmacokinetic parameters for PF-00251802: Cmax for Day 1 and Day 12
timeFrame: Day 1 to Day 15 in Cohort B
measure: Plasma pharmacokinetic parameters for PF-00251802: Tmax for Day 1 and Day 12
timeFrame: Day 1 to Day 15 in Cohort B
measure: Plasma pharmacokinetic parameters for PF-00251802: AUCtau for Day 1 and Day 12
timeFrame: Day 1 to Day 15 in Cohort B
measure: Plasma pharmacokinetic parameters for PF-00251802: As data permit t1/2 for Day12
timeFrame: Day 1 to Day 15 in Cohort B
measure: Plasma pharmacokinetic parameters for PF-00251802: As data permit Rac (accumulation ratio = Day 12 AUCtau/Day 1 AUCtau) for Day12
timeFrame: Day 1 to Day 15 in Cohort B
measure: Plasma pharmacokinetic parameters for PF-00251802: Ctrough
timeFrame: Day 1 to Day 15 in Cohort B
measure: Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Cmax for Day 1 and Day 12
timeFrame: Day 1 to Day 15 in Cohort B
measure: Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Tmax for Day 1 and Day 12
timeFrame: Day 1 to Day 15 in Cohort B
measure: Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): AUCtau for Day 1 and Day 12
timeFrame: Day 1 to Day 15 in Cohort B
measure: Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit t1/2 for Day12
timeFrame: Day 1 to Day 15 in Cohort B
measure: Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit Rac (accumulation ratio = Day 12 AUCtau/Day 1 AUCtau) for Day12
timeFrame: Day 1 to Day 15 in Cohort B
measure: Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Ctrough
timeFrame: Day 1 to Day 15 in Cohort B
Secondary outcomes:
measure: 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).
timeFrame: Day 0 to Day 15 in Cohort B
measure: Biomarkers for carbohydrate and metabolic: Plasma cortisol, serum glucose, plasma insulin and serum adiponectin.
timeFrame: Day 0 to Day 15 in Cohort B
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: