A Phase 1, Non-randomized, Open-label, Single-dose, Parallel Cohort Study to Compare the Pharmacokinetics of PF-06882961 in Adult Participants With Varying Degrees of Hepatic Impairment Relative to Participants Without Hepatic Impairment.

Registration

Registration

NCT04604496

Study type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Phase

PHASE1

Masking

SINGLE

Status

COMPLETED

Enrollment

24

Start

2020-12-30

Primary completion

2022-01-10

Lead sponsor

Pfizer

Conditions

Hepatic Impairment; Healthy Volunteers

Interventions

DRUG:PF-06882961 20MG

Results posted

TRUE

Individual participant data sharing

NO

Registered primary outcomes

• Maximum Plasma Concentration (Cmax) [Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.]
• Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) [Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.]
• Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) [Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.]
• Fraction of Unbound Drug in Plasma (fu) [Predose (0 hours), and 4 hours post dose on Day 1.]