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

NCT03597217 | Completed Phase 1 FDA Drug

• 1 other identifier: C1171013
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (14)

• Cohort A: Number of Subjects experiencing an Adverse Event

  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

Study Arms (3)

Cohort A_Active

EXPERIMENTAL

3 single doses treatment of PF-05221304

Drug: PF-05221304

Cohort B_Active

EXPERIMENTAL

Repeated doses of PF-05221304

Drug: PF-05221304

Cohort B_Placebo

PLACEBO COMPARATOR

Repeated doses of placebo

Drug: Placebo

Interventions

PF-05221304 DRUG

3, 10, 50 mg

Cohort A_Active

Placebo DRUG

Placebo

Cohort B_Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

P-one Clinic, Keikokai Medical Corporation

Hachioji-shi, Tokyo, 192-0071, Japan

Location

Related 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.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 24, 2018
• Study Start: August 27, 2018
• Primary Completion: November 15, 2018
• Study Completion: November 15, 2018
• Last Updated: November 27, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)