AN 8-WEEK, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED PHASE 1 STUDY TO EVALUATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND TOLERABILITY OF PF-06882961 IN CHINESE ADULTS WITH TYPE 2 DIABETES MELLITUS

Registration

Registration

NCT04889157

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

DOUBLE

Status

COMPLETED

Enrollment

20

Start

2021-07-07

Primary completion

2022-02-17

Lead sponsor

Pfizer

Conditions

Diabetes Mellitus, Type 2

Interventions

DRUG:PF-06882961; DRUG:Placebo

Results posted

TRUE

Individual participant data sharing

NO

Registered primary outcomes

• Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC24) of PF-06882961 10 mg Single Dose on Day 1 [Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1]
• Maximum Observed Concentration (Cmax) of PF-06882961 10 mg Single Dose on Day 1 [Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1]
• AUC24 of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961 [Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID)]
• Maximum Observed Concentration, Steady State (Cmax,ss) of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961 [Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID)]