A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO EVALUATE THE PHARMACOKINETICS OF PF-06882961 IN PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT RENAL IMPAIRMENT

Registration

Registration

NCT04616027

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

42

Start

2021-01-13

Primary completion

2022-02-18

Lead sponsor

Pfizer

Conditions

Diabetes Mellitus, Type 2; Renal Impairment; Healthy

Interventions

DRUG:PF-06882961 20 mg

Results posted

TRUE

Individual participant data sharing

NO

Registered primary outcomes

• Maximum Observed Plasma Concentration (Cmax) of Plasma PF-06882961 [0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3]
• Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Plasma PF-06882961 [0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3]
• Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of Plasma PF-06882961 [0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3]
• Fraction Unbound (fu) of Plasma PF-06882961 [0 (pre dose), 4 hours (post dose) on Day 1]