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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: PF-05221304; Drug: PF-05221304

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Hachioji-shi, Tokyo, Japan, 192-0071
      • P-one clinic, Keikokai medical corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A_Active; 3 single doses treatment of PF-05221304	Drug: PF-05221304; 3, 10, 50 mg; Drug: PF-05221304; 50 mg multiple dose
Experimental: Cohort B_Active; Repeated doses of PF-05221304	Drug: PF-05221304; 3, 10, 50 mg; Drug: PF-05221304; 50 mg multiple dose
Placebo Comparator: Cohort B_Placebo; Repeated doses of placebo	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and 12 lead ECG.	Screening up to 28 days after last dose of study medication

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort A: Number of Subjects experiencing an Adverse Event	Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and 12 lead ECG.	Screening up to 28 days after last dose of study medication
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
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 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: 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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2018
• Primary Completion (Actual): November 15, 2018
• Study Completion (Actual): November 15, 2018

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 26, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: PF-05221304, PK, Japanese, NASH, ACC inhibitor
• Other Study ID Numbers: C1171013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes