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

Primary Purpose

Diabetes Mellitus Type 2

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PF-07081532

Placebo

Clopidogrel

About this trial

This is an interventional basic science trial for Diabetes Mellitus Type 2

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Anaheim Clinical Trials, LLC
Qps-Mra, Llc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Active Obesity

Placebo Obesity

Active T2DM

Placebo T2DM

Arm Description

Part B

Parts A and C

Outcomes

Primary Outcome Measures

Number of Participants with Treatment Emergent Treatment-Related Adverse Events

Number of Participants with Laboratory Abnormalities

Number of Participants with Clinically Significant Change from Baseline in Vital Signs

Number of Participants with Abnormal Electrocardiogram

Secondary Outcome Measures

AUC24: Area under the Curve from time zero to 24 hours post dose.

Cmax: Maximum Observed Plasma Concentration

Tmax: Time to Reach Maximum Observed Plasma Concentration

t 1/2: Time measured for the plasma concentration to decrease by one-half.

Ae24: Cumulative Amount of Drug Recovered Unchanged in Urine

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.

Ae24%: Percentage of dose recovered in urine as unchanged drug

Calculated as 100 x Ae24 divided by the dose administered

CLr: Renal Clearance

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.

Full Information

NCT ID

NCT04305587

First Posted

March 9, 2020

Last Updated

September 21, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT04305587

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

March 16, 2020 (Actual)

Primary Completion Date

July 14, 2021 (Actual)

Study Completion Date

July 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus Type 2

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Masking Description

double-blind (investigator- and participant-blind), sponsor-open

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Obesity

Arm Type

Experimental

Arm Description

Part B

Arm Title

Placebo Obesity

Arm Type

Placebo Comparator

Arm Description

Part B

Arm Title

Active T2DM

Arm Type

Experimental

Arm Description

Parts A and C

Arm Title

Placebo T2DM

Arm Type

Placebo Comparator

Arm Description

Parts A and C

Intervention Type

Drug

Intervention Name(s)

PF-07081532

Intervention Description

Investigational Drug once daily for up to 42 days; multiple ascending dose design.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo once daily for up to 42 days.

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Other Intervention Name(s)

Plavix

Intervention Description

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.

Primary Outcome Measure Information:

Title

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.

Title

Number of Participants with Laboratory Abnormalities

Time Frame

From Baseline to 7-14 days following last dose administration.

Title

Number of Participants with Clinically Significant Change from Baseline in Vital Signs

Time Frame

From Baseline to 7-14 days following last dose administration.

Title

Number of Participants with Abnormal Electrocardiogram

Time Frame

From Baseline to 7-14 days following last dose administration.

Secondary Outcome Measure Information:

Title

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.

Title

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.

Title

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.

Title

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.

Title

Ae24: Cumulative Amount of Drug Recovered Unchanged in Urine

Description

Time Frame

Part A: Day 28 (0-24 hrs). Part C (if conducted): Day 42 (0-24 hrs).

Title

Ae24%: Percentage of dose recovered in urine as unchanged drug

Description

Calculated as 100 x Ae24 divided by the dose administered

Time Frame

Part A: Day 28 (0-24 hrs). Part C (if conducted): Day 42 (0-24 hrs).

Title

CLr: Renal Clearance

Description

Time Frame

Part A: Day 28 (0-24 hrs). Part C (if conducted): Day 42 (0-24 hrs).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Anaheim Clinical Trials, LLC

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Qps-Mra, Llc

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=C3991002

Description

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

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