NCT06340347

A Study to Learn How the Body Processes the Study Medicine Called Osivelotor (PF-07940367) in People With Loss of Liver Function

A PHASE 1, OPEN-LABEL, SINGLE-DOSE, NON-RANDOMIZED PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF OSIVELOTOR (PF-07940367) IN ADULT PARTICIPANTS WITH MILD AND MODERATE HEPATIC IMPAIRMENT

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to understand how Osivelotor is processed in people with loss of liver function. This study is seeking participants that are: * stable loss of liver function with mild or moderate severity * none of underlying conditions possibly affecting the study medicine being absorbed by the body All participants will receive one amount of Osivelotor by mouth before breakfast on the first day at the study clinic. A number of blood samples will be collected to understand how Osivelotor is changed and removed from the body. Participants will also have to undergo physical examination and other tests. This will help to understand if Osivelotor is safe. Participants will take part in the study for a maximum of 112 days. During this time, participants will have to stay onsite for 5 days. There will be 5 study visits at the study clinic.

Conditions

• Liver Diseases

Interventions

Type	Name	Description
DRUG	Osivelotor	a single dose of osivelotor administered by mouth under fasted conditions Other Names: PF-07940367

Timeline

• Start date: 2024-04-30
• Primary completion: 2024-09-18
• Completion: 2024-09-18
• First posted: 2024-04-01
• Last updated: 2025-01-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study