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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06882961 in Japanese 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: NCT04552470
Recruitment Status : Completed
First Posted : September 17, 2020
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This is a Phase 1, randomized, double blind (sponsor open), parallel, placebo controlled, twice daily oral dosing study of PF 06882961 in adult Japanese participants with T2DM inadequately controlled on diet and exercise alone.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Placebo Drug: PF-06882961 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: AN 8-WEEK PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF TWICE DAILY PF-06882961 ADMINISTRATION IN JAPANESE ADULTS WITH TYPE 2 DIABETES MELLITUS
Actual Study Start Date : October 26, 2020
Actual Primary Completion Date : February 21, 2021
Actual Study Completion Date : March 25, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
3 matching placebo tablets taken twice a day (BID)

Experimental: PF-06882961 40 mg
Participants will be titrated up to 2 weeks to reach desired dose level
Drug: PF-06882961
Participants will be randomized to one of 3 active doses (40, 80, or 120 mg), taking 3 tablets twice daily for 8 weeks.

Experimental: PF-06882961 80 mg
Participants will be titrated up to 4 weeks to reach desired dose level
Drug: PF-06882961
Participants will be randomized to one of 3 active doses (40, 80, or 120 mg), taking 3 tablets twice daily for 8 weeks.

Experimental: PF-06882961 120 mg
Participants will be titrated up to 6 weeks to reach desired dose level
Drug: PF-06882961
Participants will be randomized to one of 3 active doses (40, 80, or 120 mg), taking 3 tablets twice daily for 8 weeks.




Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Treatment-Related Adverse Events [ Time Frame: Baseline up to 35 days after last dose (Day 91) ]
  2. Number of Participants With Laboratory Abnormalities [ Time Frame: Baseline up to 14 days after last dose (Day 70) ]
  3. Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Baseline up to 14 days after last dose (Day 70) ]
  4. Number of Participants With Abnormal Electrocardiogram (ECG) [ Time Frame: Baseline up to 14 days after last dose (Day 70) ]

Secondary Outcome Measures :
  1. Area under the Concentration-Time Curve [ Time Frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours on Day 1; 0, 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56; ]
  2. Maximum Observed Plasma Concentration [ Time Frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours on Day 1; 0, 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56; ]
  3. Time to Reach Maximum Observed Plasma Concentration [ Time Frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours on Day 1; 0, 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56; ]
  4. Plasma Terminal Half-Life [ Time Frame: 0, 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56; ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with T2DM who are treated with diet and exercise
  • HbA1c greater than or equal to 7% and less than or equal to 10.5%
  • Total body weight >50 kg (110 lb) with BMI 22.5 to 45.4 kg/m^2

Exclusion Criteria:

  • Any condition possibly affecting drug absorption
  • Diagnosis of Type 1 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
  • Symptomatic gallbladder disease
  • Known medical history of active proliferative retinopathy and/or macular edema
  • Known history of HIV, hepatitis B, hepatitis C or syphilis
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04552470


Locations
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Japan
P-one clinic, Keikokai medical corporation
Hachioji, Tokyo, Japan, 192-0071
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04552470    
Other Study ID Numbers: C3421015
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
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.

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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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases