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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04889157
Recruitment Status : Completed
First Posted : May 17, 2021
Last Update Posted : March 14, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 12, 2021
First Posted Date  ICMJE May 17, 2021
Last Update Posted Date March 14, 2022
Actual Study Start Date  ICMJE July 7, 2021
Actual Primary Completion Date February 17, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2021)
  • Area under the concentration-time curve [ Time Frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours on Days 1, 21, 35 and 56 ]
  • Maximum observed plasma concentration [ Time Frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours on Days 1, 21, 35 and 56 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2021)
  • Number of participants with clinically significant change from baseline in vital signs [ Time Frame: Baseline up to 14 days after last dose (Day 70) ]
  • Number of participants with abnormal Electrocardiogram (ECG) [ Time Frame: Baseline up to 14 days after last dose (Day 70) ]
  • Number of participants with treatment emergent treatment-related adverse events [ Time Frame: Baseline up to 35 days after last dose (Day 91) ]
  • Number of participants with laboratory abnormalities [ Time Frame: Baseline up to 14 days after last dose (Day 70) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: PF-06882961
    Participants will be administered active doses, taking 3 tablets twice daily (BID) for 8 weeks except Day 1 (QD)
  • Drug: Placebo
    3 matching placebo tablets taken twice daily (BID) except Day 1 (QD)
Study Arms  ICMJE
  • Experimental: PF-06882961
    Participants will be titrated up to 6 weeks of the 8-week dosing duration to reach desired dose level 120 mg
    Intervention: Drug: PF-06882961
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2021)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 17, 2022
Actual Primary Completion Date February 17, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04889157
Other Study ID Numbers  ICMJE C3421028
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Current Responsible Party Pfizer
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pfizer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP