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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
20
Participants will be administered active doses, taking 3 tablets twice daily (BID) for 8 weeks except Day 1 (QD)
3 matching placebo tablets taken twice daily (BID) except Day 1 (QD)
Peking University Third Hospital
Beijing, China
Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC24) of PF-06882961 10 mg Single Dose on Day 1
AUC24 is the area under the plasma concentration-time profile from time zero to the time 24 hours. The planned analysis was not considered reliable by the sponsor.
Time frame: 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
Cmax is the maximum observed plasma concentration over 24 hours. The planned analysis was not considered reliable by the sponsor.
Time frame: 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
AUC24 was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor.
Time frame: 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
Cmax,ss was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor.
Time frame: 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)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Supine blood pressure and pulse rate were measured with the participant's arm supported at the level of the heart and recorded to the nearest mmHg after approximately 5 minutes of rest and maximum absolute values and maximum changes from baseline from time-matched baseline were evaluated at the investigator's discretion.
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Time frame: Baseline up to 14 days after last dose (Day 70)
Number of Participants With Abnormal Electrocardiogram (ECG)
Standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate and measures PR, QT, and QT interval corrected for heart rate (QTc) and QRS complex.
Time frame: Baseline up to 14 days after last dose (Day 70)
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event was defined as any untoward medical occurrence that,at any dose:resulted in death;was life-threatening;required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent disability/incapacity; was a congenital anomaly/birth defect;or other serious situations such as important medical events. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.
Time frame: Baseline up to 35 days after last dose (Day 91)
Number of Participants With Laboratory Abnormalities
Laboratory tests (including hematological, clinical chemistry, urinalysis tests) were reported and abnormality was determined at the investigator's discretion.
Time frame: Baseline up to 14 days after last dose (Day 70)