A Study to Understand How the Body Processes [14C]PF-07104091 in Healthy Participants

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Adults

Treatments: Drug: PF-07104091

Study type: Interventional

Funder types: Industry

Identifiers

NCT07127770

C4161006

2024-518696-65-00 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to learn how the body processes the study medicine PF-07104091.

The study is seeking participants who are:

- Healthy male aged 18 to 65 years of age

Participants in the study will receive 14C-labeled PF-07104091 by mouth after a meal. After 14 days, the participants will receive PF-07104091 by mouth (after a meal) followed by IV fusion (given directly into a vein) of microdose [14C]PF-07104091.

The study will help understand how the body processes study medicine PF-07104091 and how the medicine is changed and removed from the body after you take it. This study will also help to understand how much PF-07104901 is taken up into the blood.

Participants will remain in the study clinic for a maximum of 23 days and will have one follow-up contact.

Enrollment: 9 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and standard 12-lead ECGs.
• Body mass index (BMI) of 17.5-32.0 kg/m2 inclusive and a total body weight >50 kg (110 lb)
• Evidence of a personally signed and dated Informed Consent Document (ICD) indicating that the participant has been informed of all pertinent aspects of the study.
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Regimen A; Period 1

Experimental group

Description:

Single oral dose of 14C-labeled PF-07104091 administered under fed conditions.

Treatment:

Drug: PF-07104091

Regimen B; Period 2

Experimental group

Description:

Single oral dose of unlabeled PF-07104091 administered under fed conditions followed by an intravenous (IV) infusion of PF-07104091 containing a microdose of 14C-labeled PF-07104091.

Treatment:

Drug: PF-07104091