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Completed

NCT Number: NCT04889157

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Third Hospital

Beijing, 100089, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-06882961

Drug

Participants will be administered active doses, taking 3 tablets twice daily (BID) for 8 weeks except Day 1 (QD)

Placebo

Drug

3 matching placebo tablets taken twice daily (BID) except Day 1 (QD)

Primary outcomes

  1. Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC24) of PF-06882961 10 mg Single Dose on Day 1

    Time frame: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post 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.

  2. Maximum Observed Concentration (Cmax) of PF-06882961 10 mg Single Dose on Day 1

    Time frame: Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1

    Cmax is the maximum observed plasma concentration over 24 hours. The planned analysis was not considered reliable by the sponsor.

  3. AUC24 of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961

    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)

    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.

  4. 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

    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)

    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.

Secondary outcomes

  1. Number of Participants With Clinically Significant Change From Baseline in Vital Signs

    Time frame: Baseline up to 14 days after last dose (Day 70)

    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.

  2. Number of Participants With Abnormal Electrocardiogram (ECG)

    Time frame: Baseline up to 14 days after last dose (Day 70)

    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.

  3. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

    Time frame: Baseline up to 35 days after last dose (Day 91)

    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.

  4. Number of Participants With Laboratory Abnormalities

    Time frame: Baseline up to 14 days after last dose (Day 70)

    Laboratory tests (including hematological, clinical chemistry, urinalysis tests) were reported and abnormality was determined at the investigator's discretion.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 17, 2021
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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