Clinical trial NCT04889157: A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-05-17
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a Phase 1, randomized, double-blind (sponsor open), placebo controlled study in adult Chinese participants with T2DM who are receiving metformin as background antihyperglycemic medication.


Eligibility criteria: Inclusion Criteria:

* Patients with T2DM who are taking metformin monotherapy as their only antihyperglycemic treatment
* HbA1c greater than or equal to 7% and less than or equal to 10.5%
* Total body weight \>50 kg (110 lb) with BMI of 22.5 to 45.4 kg/m\^2

Exclusion Criteria:

* Any condition possibly affecting drug absorption
* Diagnosis of Type 1 diabetes mellitus or secondary forms of diabetes
* History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of Screening
* Any malignancy not considered cured
* Personal or family history of MTC or MEN2, or participants with suspected MTC
* Acute pancreatitis or history of chronic pancreatitis
* Acute gallbladder disease
* Known history of HIV, hepatitis B, hepatitis C or syphilis, or positive testing of them
* Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
* Clinically relevant ECG abnormalities
* Positive urine drug test
* Clinical relevant laboratory tests abnormalities

Primary outcomes:
measure: Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC24) of PF-06882961 10 mg Single Dose on Day 1
timeFrame: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1
measure: Maximum Observed Concentration (Cmax) of PF-06882961 10 mg Single Dose on Day 1
timeFrame: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1
measure: AUC24 of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961
timeFrame: 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)
measure: 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
timeFrame: 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)
Secondary outcomes:
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: Baseline up to 14 days after last dose (Day 70)
measure: Number of Participants With Abnormal Electrocardiogram (ECG)
timeFrame: Baseline up to 14 days after last dose (Day 70)
measure: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
timeFrame: Baseline up to 35 days after last dose (Day 91)
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline up to 14 days after last dose (Day 70)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: