A Study to Learn How Different Forms of the Study Medicine Called PF-07976016 Are Taken Up Into the Blood in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-05

Study Completion Date

2025-01-17

Brief Summary

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The primary purpose of this study is to measure and compare the amount of study drug in your blood after a single dose of two formulations of study drug.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sequence 1

Participants will receive a single dose of PF-07976016 in up to 3 study periods. In sequence 1, participants will receive formulation A followed by formulation B. There will be 7 days between each dose as a wash out period.

Group Type EXPERIMENTAL

PF-07976016 Formulation A

Intervention Type DRUG

PF-07976016; formulation A - current/reference

PF-07976016 Formulation B

Intervention Type DRUG

PF-07976016; Formulation B - new/test

Sequence 2

Participants will receive single doses of PF-07976016 in up to 3 study periods. In sequence 2, participants will receive formulation B followed by formulation A. There will be 7 days between each dose as a wash out period.

Group Type EXPERIMENTAL

PF-07976016 Formulation A

Intervention Type DRUG

PF-07976016; formulation A - current/reference

PF-07976016 Formulation B

Intervention Type DRUG

PF-07976016; Formulation B - new/test

Interventions

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PF-07976016 Formulation A

PF-07976016; formulation A - current/reference

Intervention Type DRUG

PF-07976016 Formulation B

PF-07976016; Formulation B - new/test

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECG assessments.
* Willing to provide consent and follow study requirements
* Total body weight \>110lbs (50kg)

Exclusion Criteria

* Any condition affecting drug absorption, clinically significant laboratory values
* HIV, HepB \& HepC
* Serious illness or hospitalization, or other condition, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Use of prescription or non-prescription drugs within a specified timeframe prior to the first dose of study intervention
* positive urine drug test at screening/admission
* History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening
* Use of tobacco/nicotine containing products more than the equivalent of 5 cigarettes/day or 2 chews of tobacco/day

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes