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Multiple Escalating Oral Doses Study of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT04305587
Recruitment Status : Completed
First Posted : March 12, 2020
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:

This is a randomized, placebo-controlled, double-blind (investigator- and participant-blinded), sponsor-open, dose-escalating study of PF-07081532 in patients with Type 2 diabetes on metformin (Parts A and C). The study may also enroll non-diabetic participants with obesity (Part B). Study participants will receive an investigational product or placebo every day for up to 28 days (Part A) or up to 42 days (Part B, optional; Part C, optional).

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of PF-07081532 in participants with inadequately controlled T2DM on metformin and optionally in non-diabetic obese participants.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: PF-07081532 Other: Placebo Drug: Clopidogrel Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description: double-blind (investigator- and participant-blind), sponsor-open
Primary Purpose: Basic Science
Official Title: A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
Actual Study Start Date : March 16, 2020
Actual Primary Completion Date : July 14, 2021
Actual Study Completion Date : July 14, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Obesity
Part B
Other: Placebo
Placebo once daily for up to 42 days.

Drug: Clopidogrel
Part B may include a drug-drug interaction study using open-label clopidogrel. Clopidrogrel may be given as two single doses of 75 mg administered on day -2 and day 41.
Other Name: Plavix

Placebo Comparator: Placebo Obesity
Part B
Other: Placebo
Placebo once daily for up to 42 days.

Drug: Clopidogrel
Part B may include a drug-drug interaction study using open-label clopidogrel. Clopidrogrel may be given as two single doses of 75 mg administered on day -2 and day 41.
Other Name: Plavix

Experimental: Active T2DM
Parts A and C
Drug: PF-07081532
Investigational Drug once daily for up to 42 days; multiple ascending dose design.

Placebo Comparator: Placebo T2DM
Parts A and C
Drug: PF-07081532
Investigational Drug once daily for up to 42 days; multiple ascending dose design.




Primary Outcome Measures :
  1. Number of Participants with Treatment Emergent Treatment-Related Adverse Events [ Time Frame: Baseline up to a minimum of 28 days after last administration of investigational product. ]
  2. Number of Participants with Laboratory Abnormalities [ Time Frame: From Baseline to 7-14 days following last dose administration. ]
  3. Number of Participants with Clinically Significant Change from Baseline in Vital Signs [ Time Frame: From Baseline to 7-14 days following last dose administration. ]
  4. Number of Participants with Abnormal Electrocardiogram [ Time Frame: From Baseline to 7-14 days following last dose administration. ]

Secondary Outcome Measures :
  1. AUC24: Area under the Curve from time zero to 24 hours post dose. [ Time Frame: Part A: 0-24 hours post-dose on selected study days from day 1 to day 28. Parts B/C (if conducted): 0-24 hours post-dose on selected study days from day 1 to day 42. ]
  2. Cmax: Maximum Observed Plasma Concentration [ Time Frame: Part A: selected study days from day 1 to day 28. Parts B/C (if conducted): selected study days from day 1 to day 42. ]
  3. Tmax: Time to Reach Maximum Observed Plasma Concentration [ Time Frame: Part A: selected study days from day 1 to day 28. Parts B/C (if conducted): selected study days from day 1 to day 42. ]
  4. t 1/2: Time measured for the plasma concentration to decrease by one-half. [ Time Frame: Part A: Day 28 0-72 hours post-dose. Parts B/C (if conducted): also day 42 0-72 hours post-dose. ]
  5. Ae24: Cumulative Amount of Drug Recovered Unchanged in Urine [ Time Frame: Part A: Day 28 (0-24 hrs). Part C (if conducted): Day 42 (0-24 hrs). ]
    Ae24 is the cumulative amount of drug recovered unchanged in urine over 24 hours. Cumulative amount is calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020) where 1.020 g/mL is the approximate specific gravity of urine.

  6. Ae24%: Percentage of dose recovered in urine as unchanged drug [ Time Frame: Part A: Day 28 (0-24 hrs). Part C (if conducted): Day 42 (0-24 hrs). ]
    Calculated as 100 x Ae24 divided by the dose administered

  7. CLr: Renal Clearance [ Time Frame: Part A: Day 28 (0-24 hrs). Part C (if conducted): Day 42 (0-24 hrs). ]
    Renal clearance is calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae24) divided by area under the plasma concentration time curve from time zero to end of dosing interval (AUC24), where dosing interval is 24 hours.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria for participants enrolling with T2DM:

  • Type 2 Diabetes treated with a stable dose of metformin at least 500 mg per day for at least 2 months prior to screening visit and use of no other medications for glycemic control.
  • HbA1c value between 7.0% and 10.5%, inclusive.

Key Exclusion Criterion for participants enrolling with T2DM:

-Type 1 Diabetes or secondary forms of diabetes.

Key Inclusion Criterion for participants enrolling with obesity:

-Obese (as indicated by screening BMI) non-diabetic adults.

Key Exclusion Criterion for participants enrolling with obesity:

--Type 1 or Type 2 Diabetes or secondary forms of diabetes.


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): NCT04305587


Locations
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United States, California
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
United States, Florida
Qps-Mra, Llc
South Miami, Florida, United States, 33143
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: NCT04305587    
Other Study ID Numbers: C3991002
First Posted: March 12, 2020    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs