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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: PF-07976016 Formulation A; Drug: PF-07976016 Formulation B

Study type: Interventional

Funder types: Industry

Identifiers

NCT06670170

C5541005

NCT06670170 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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)

Key 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Sequence 1

Experimental group

Description:

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.

Treatment:

Drug: PF-07976016 Formulation B

Drug: PF-07976016 Formulation A

Sequence 2

Experimental group

Description:

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.

Treatment:

Drug: PF-07976016 Formulation B

Drug: PF-07976016 Formulation A