A Single and Multiple Dose Study of PF-05221304 in Healthy Japanese Adults

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03597217

Enrollment

Registered

2018-07-24

Start date

2018-08-27

Completion date

2018-11-15

Last updated

2018-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

PF-05221304, PK, Japanese, NASH, ACC inhibitor

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.

Interventions

DRUGPF-05221304

3, 10, 50 mg

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Cohort A: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (AUClast)	0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose	—
Cohort A: Maximum observed plasma concentration (Cmax)	0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose	—
Cohort A: Time to reach Cmax (Tmax)	0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose	—
Cohort A: Area under the plasma concentration time profile from time zero extrapolated to infinite time (as data permit) (AUCinf)	0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose	—
Cohort A: Terminal half life (as data permit) (t1/2)	0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose	—
Cohort A: Apparent clearance (as data permit) (CL/F)	0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose	—
Cohort A: Apparent volume of distribution (as data permit) (Vz/F)	0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose	—
Cohort B: Number of Subjects experiencing an Adverse Event	Screening up to 28 days after last dose of study medication	Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and 12 lead ECG.

Secondary

Measure	Time frame	Description
Cohort B: Peak trough ratio (PTR)(Day 14)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose	—
Cohort B: Observed accumulation ratio (Rac)(Day 14)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose	—
Cohort B: Observed accumulation ratio for Cmax (Rac,Cmax)(Day 14)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose	—
Cohort A: Number of Subjects experiencing an Adverse Event	Screening up to 28 days after last dose of study medication	Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and 12 lead ECG.
Cohort B: Apparent volume of distribution (Vz/F)(Day 14)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose	—
Cohort B: Apparent clearance (CL/F)(Day 14)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose	—
Cohort B: Terminal half life (t1/2)(Day 14)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose	—
Cohort B: Area under the plasma concentration time profile from time zero to time τ (tau), the dosing interval (ACUtau)(Day 1)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose	—
Cohort B: Area under the plasma concentration time profile from time zero to time τ (tau), the dosing interval (ACUtau)(Day 14)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose	—
Cohort B: Maximum plasma concentration during the dosing interval (Cmax)(Day 1)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose	—
Cohort B: Maximum plasma concentration during the dosing interval (Cmax)(Day 14)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose	—
Cohort B: Time to reach Cmax (Tmax)(Day 1)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose	—
Cohort B: Time to reach Cmax (Tmax)(Day 14)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose	—
Cohort B: Minimum plasma concentration during the dosing interval (Cmin)(Day 14)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026