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Relative Bioavailability Study of a Modified-Release Formulation of PF-06865571 in Healthy Adult Participants

NCT04044053 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-11-27

No results posted yet for this study

Summary

This study is an open-label, randomized, single-dose, 4-period, 4-sequence, crossover study in a single cohort of approximately 12 healthy adult participants. The purpose of this study is to evaluate the relative bioavailability of a newly developed modified release (MR) tablet formulation of PF-06865571 relative to an immediate release (IR) tablet formulation of PF-06865571 under fed conditions. In addition, this study will also assess the relative bioavailability of the MR formulation under fasted conditions relative to fed conditions, in healthy adult participants. Study results will be used to determine if the new MR formulation may be suitable for use in future clinical studies with PF-06865571. Healthy adult Japanese participants will also be enrolled in this study to support inclusion of Japanese participants in future clinical studies.

Conditions

  • Healthy Participants

Interventions

DRUG

PF-06865571 400 mg Immediate Release (IR) in Fed State

400 mg IR dose in fed state

DRUG

PF-06865571 50 mg Modified Release (MR) in Fed State

50 mg MR in fed state

DRUG

PF-06865571 400 mg MR in Fed State

400 mg MR in fed state

DRUG

PF-06865571 400 mg MR in Fasted State

400 mg MR in fasted state

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-13
Primary Completion
2019-10-31
Completion
2019-10-31
FDA Drug
Yes

Countries

  • Belgium

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04044053 on ClinicalTrials.gov