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

NCT ID: NCT04044053

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-13
• Study Completion Date: 2019-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Relative Bioavailability

Each participant will receive 400 mg IR, 400 mg MR, and 50 mg MR in the fed state, and 400 mg MR in the fasted state

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

400 mg IR dose in fed state

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

Intervention Type: DRUG

50 mg MR in fed state

PF-06865571 400 mg MR in Fed State

Intervention Type: DRUG

400 mg MR in fed state

PF-06865571 400 mg MR in Fasted State

Intervention Type: DRUG

400 mg MR in fasted state

Fasted State

Comparison of 400 mg MR in fed and fasted states

Group Type: EXPERIMENTAL

PF-06865571 400 mg MR in Fed State

Intervention Type: DRUG

400 mg MR in fed state

PF-06865571 400 mg MR in Fasted State

Intervention Type: DRUG

400 mg MR in fasted state

Interventions

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

400 mg IR dose in fed state

Intervention Type: DRUG

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

50 mg MR in fed state

Intervention Type: DRUG

PF-06865571 400 mg MR in Fed State

400 mg MR in fed state

Intervention Type: DRUG

PF-06865571 400 mg MR in Fasted State

400 mg MR in fasted state

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female participants of non-childbearing potential and male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac tests.
• Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
• Participants enrolling as Japanese must have 4 biological Japanese grandparents who were born in Japan.

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).
• Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
• Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product used in this study (whichever is longer).
• Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest.
• Baseline 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline corrected QT (QTc) interval >450 msec, complete left bundle branch block [LBBB], signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias).
• Participants with any of the following abnormalities in clinical laboratory tests at screening: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥1.25× upper limit of normal (ULN); Total bilirubin level ≥1.5× ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Brussels Clinical Research Unit

Brussels, Be-bru, Belgium

Countries

Belgium

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C2541012

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Other Identifiers

2019-001426-96

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C2541012

Identifier Type: -

Identifier Source: org_study_id