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

• ClinicalTrials.gov Identifier: NCT04552470
• Recruitment Status: Recruiting
• First Posted: September 17, 2020
• Last Update Posted: November 3, 2020
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: September 11, 2020
• First Posted Date: September 17, 2020
• Last Update Posted Date: November 3, 2020
• Actual Study Start Date: October 26, 2020
• Estimated Primary Completion Date: January 11, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 11, 2020)

• 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) ]
• 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) ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 11, 2020)

• 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; ]
• 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; ]
• 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; ]
• Plasma Terminal Half-Life [ Time Frame: 0, 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56; ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06882961 in Japanese Adults With Type 2 Diabetes Mellitus
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Type 2 Diabetes Mellitus

Intervention

• Drug: Placebo
  3 matching placebo tablets taken twice a day (BID)
• 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.

Study Arms

• Placebo Comparator: Placebo
  Intervention: Drug: Placebo
• Experimental: PF-06882961 40 mg
  Participants will be titrated up to 2 weeks to reach desired dose level
  Intervention: Drug: PF-06882961
• Experimental: PF-06882961 80 mg
  Participants will be titrated up to 4 weeks to reach desired dose level
  Intervention: Drug: PF-06882961
• Experimental: PF-06882961 120 mg
  Participants will be titrated up to 6 weeks to reach desired dose level
  Intervention: Drug: PF-06882961

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 11, 2020): 36
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 15, 2021
• Estimated Primary Completion Date: January 11, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Pfizer CT.gov Call Center; 1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT04552470
• Other Study ID Numbers: C3421015
• Has Data Monitoring Committee: No

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

• 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.

• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: November 2020