A Study to Understand How the Study Medicine (PF-07976016) is Processed and Eliminated in Healthy Men

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Male Volunteers

Treatments: Drug: PF-07976016; Drug: [14C] PF-07976016

Study type: Interventional

Funder types: Industry

Identifiers

NCT07015918

C5541002

2024-518535-11-00 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to learn about how much the study medicine PF-07976016 will be taken up and processed by healthy male participants. The total number of weeks of the study is up to approximately 12 weeks.

Enrollment: 8 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males, 18 to 65 years of age
• BMI 17.5 to 32 kg/m2 and a total body weight >50 kg (110 lb)
• Willing and able to comply with all study procedures

Exclusion criteria

• History of irregular bowel movements or lactose intolerance
• Any medical or psychiatric condition or laboratory abnormality or other condition that may increase the risk of study participation
• Use of any prohibited or concomitant medication(s)
• Presence of specified abnormalities on diagnostic assessments including clinical laboratory tests
• Positive urine drug test
• History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence
• Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day
• Previous administration of an investigational product within 30 days preceding the first dose of study medicine in this study.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Arm 1

Experimental group

Description:

Participants will receive doses of PF-07976016 with and without radiolabel.

Treatment:

Drug: [14C] PF-07976016

Drug: [14C] PF-07976016

Drug: PF-07976016