A Study to Understand How the Study Medicine (PF-07081532) is Processed and Eliminated in Healthy Men

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Drug: Oral PF-07081532 and IV [14C]PF-07081532

Drug: Oral [14C]PF-07081532

Study type

Interventional

Funder types

Industry

Identifiers

NCT05652647

C3991006

Details and patient eligibility

About

The purpose of this clinical trial is to learn about how much PF-07081532 will be taken up and processed by healthy male participants. The study consists of two parts, called study periods. In Period 1, participants will take one dose of PF-07081532 by mouth. In Period 2, participants will take one dose by mouth and one dose as an injection through a vein at the study clinic.

In Period 1, participants will stay at the clinic site for up to 21 days. In Period 2, they will stay at the clinic site for 7 days. During their stays, participants will have their blood, urine, and feces collected by the study doctors several times. We will measure the level of PF-07081532 in participants' blood, urine, and feces samples. This will help us know how much the study medicine is getting taken in by the body. At the end of the study, participants will be contacted by phone to check in. Participants will be involved in this study for about 12 weeks.

Enrollment

6 patients

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Eligibility criteria for this study include, but are not limited to the following:

Inclusion criteria:

Healthy Male participants must be 18 to 60 years of age, inclusive.

Overtly healthy as determined by medical evaluation including medical history, physical examination, blood pressure and pulse rate measurement, standard 12-lead ECG, and laboratory tests.

BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures

Exclusion criteria:

History of irregular bowel movements (eg, irritable bowel syndrome, frequent episodes of diarrhea, or constipation defined by less than 1 bowel movement on average per 2 days) or lactose intolerance

Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).

Previous administration with an investigational product (drug or vaccine) within 90 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study.

Total 14C radioactivity measured in plasma exceeding 11 mBq/mL.