Clinical trial NCT03597217: A Single and Multiple Dose Study of PF-05221304 in Healthy Japanese Adults
Official title: A Phase 1, 2-part Study Of Pf-05221304 In Healthy Japanese Adults: Part 1 - Randomized, Double-blind, Crossover, Single Dose Assessment Of Pharmacokinetics And Safety; Part 2- Randomized, Double-blind, Placebo-controlled, Multiple Dose Assessment Of Safety, Tolerability And Pharmacokinetics Of Pf-05221304
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PF-05221304, PK, Japanese, NASH, ACC inhibitor
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-07-24
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The current study is designed to evaluate the safety, tolerability and pharmacokinetics of PF-05221304 in healthy Japanese adult subjects following single and multiple dose administration.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects who, at the time of screening, are between the ages of 20 and 55 years, inclusive.
* Body mass index (BMI) of 17.5-30.5 kg/m2 inclusive; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) or clinical findings at Screening.

Primary outcomes:
measure: Cohort A: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (AUClast)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
measure: Cohort A: Maximum observed plasma concentration (Cmax)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
measure: Cohort A: Time to reach Cmax (Tmax)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
measure: Cohort A: Area under the plasma concentration time profile from time zero extrapolated to infinite time (as data permit) (AUCinf)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
measure: Cohort A: Terminal half life (as data permit) (t1/2)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
measure: Cohort A: Apparent clearance (as data permit) (CL/F)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
measure: Cohort A: Apparent volume of distribution (as data permit) (Vz/F)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
measure: Cohort B: Number of Subjects experiencing an Adverse Event
timeFrame: Screening up to 28 days after last dose of study medication
Secondary outcomes:
measure: Cohort A: Number of Subjects experiencing an Adverse Event
timeFrame: Screening up to 28 days after last dose of study medication
measure: Cohort B: Area under the plasma concentration time profile from time zero to time τ (tau), the dosing interval (ACUtau)(Day 1)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose
measure: Cohort B: Area under the plasma concentration time profile from time zero to time τ (tau), the dosing interval (ACUtau)(Day 14)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
measure: Cohort B: Maximum plasma concentration during the dosing interval (Cmax)(Day 1)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose
measure: Cohort B: Maximum plasma concentration during the dosing interval (Cmax)(Day 14)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
measure: Cohort B: Time to reach Cmax (Tmax)(Day 1)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose
measure: Cohort B: Time to reach Cmax (Tmax)(Day 14)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
measure: Cohort B: Minimum plasma concentration during the dosing interval (Cmin)(Day 14)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
measure: Cohort B: Peak trough ratio (PTR)(Day 14)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
measure: Cohort B: Observed accumulation ratio (Rac)(Day 14)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
measure: Cohort B: Observed accumulation ratio for Cmax (Rac,Cmax)(Day 14)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
measure: Cohort B: Terminal half life (t1/2)(Day 14)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
measure: Cohort B: Apparent volume of distribution (Vz/F)(Day 14)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
measure: Cohort B: Apparent clearance (CL/F)(Day 14)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose
Other outcomes:
Locations:
city: Hachioji-shi
country: Japan
facility: P-one Clinic, Keikokai Medical Corporation
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: