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A Clinical Trial of the Study Medicine (PF-07081532) in People With Diabetes and Kidney Dysfunction

Primary Purpose

Type 2 Diabetes, Renal Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PF-07081532

About this trial

This is an interventional basic science trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Renal impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Stable renal function (for participants not on dialysis) defined as ≤25% difference between 2 measurements of BSA-unnormalized eGFR
A prior diagnosis of T2DM with an HbA1c ≥6% and ≤10.5%
Women may be of child-bearing potential
BMI of 17.5 to 45.4 kg/m2
NORMAL FUNCTION (GROUP 1): Normal renal function (mean eGFR ≥90 mL/min) based on an average of measures from Screening visits S1 and S2 (eGFR should be calculated using the 2021 CKD EPI Scr-Scys combined equation:
- Demographically comparable to participants with impaired renal function at Screening
- A body weight within ±15 kg of the mean body weight of the pooled renal impairment groups (Groups 2, 3 and 4)
- An age within ±10 years of the mean age of the pooled renal impairment groups (Groups 2, 3 and 4)
- Attempts will be made to ensure that the male to female distribution in Group 1 is comparable to that in the pooled renal impairment groups (Groups 2, 3 and 4).

Exclusion Criteria:

Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes, or history of diabetic ketoacidosis.
History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II-IV heart failure, or transient ischemic attack within 3 months of Screening
Personal or family history of MTC or MEN2, or participants with suspected MTC per the investigator's judgement.
History of acute pancreatitis within 6 months before Screening or any history of chronic pancreatitis.
Urinary incontinence.
Participants with acute renal disease.
Renal allograft recipients.
Participants who have previously received a kidney, liver, or heart transplant.

Sites / Locations

Genesis Clinical Research, LLC
Prism Research LLC dba Nucleus Network

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Participants without renal impairment will receive a single 20 mg dose of PF 07081532, administered orally

Participants with mild renal impairment will receive a single 20 mg dose of PF 07081532, administered orally

Participants with moderate renal impairment will receive a single 20 mg dose of PF 07081532, administered orally

Participants with severe renal impairment will receive a single 20 mg dose of PF 07081532, administered orally

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax)

AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).

AUCinfu= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for unbound drug

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClastu) for unbound drug.

Cmax, u is the highest measured unbound plasma concentration during the dosing interval.

Fraction of unbound drug in plasma; Cu/C where Cu represents unbound concentration and C represents total concentration

Secondary Outcome Measures

Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

Number of Participants With Treatment Emergent Clinically Significant Clinical Laboratory Abnormalities

Number of Participants With Treatment Emergent Clinically Significant Change from Baseline in Vital Signs Abnormalities

Number of Participants With Treatment emergent Clinically Significant Abnormal ECG

Full Information

NCT ID

NCT05510245

First Posted

August 19, 2022

Last Updated

September 18, 2023

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT05510245

Brief Title

A Clinical Trial of the Study Medicine (PF-07081532) in People With Diabetes and Kidney Dysfunction

Official Title

A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO EVALUATE THE PHARMACOKINETICS OF PF-07081532 IN ADULT PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT RENAL IMPAIRMENT

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

August 29, 2022 (Actual)

Primary Completion Date

July 20, 2023 (Actual)

Study Completion Date

July 20, 2023 (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

The purpose of this study is to understand the effects of kidney functional impairment may have on the study medicine (PF-07081532). People with certain level of kidney functional impairment may process PF-07081532 differently from healthy people. PF-07081532 is developed as a potential treatment for type II diabetes. Participants will take the study medicine as a tablet by mouth once at the study clinic and then will stay at the study clinic for about 7 days. During that time, the study team will monitor their treatment experience and take some blood samples to test the level of PF-07081532. This will help us understand if certain degree of kidney functional impairment will have an effect on the study medicine PF-07081532.

6. Conditions and Keywords

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

Type 2 Diabetes, Renal Impairment

Keywords

Type 2 Diabetes, Renal impairment

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Participants without renal impairment will receive a single 20 mg dose of PF 07081532, administered orally

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Participants with mild renal impairment will receive a single 20 mg dose of PF 07081532, administered orally

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Participants with moderate renal impairment will receive a single 20 mg dose of PF 07081532, administered orally

Arm Title

Group 4

Arm Type

Experimental

Arm Description

Participants with severe renal impairment will receive a single 20 mg dose of PF 07081532, administered orally

Intervention Type

Drug

Intervention Name(s)

PF-07081532

Intervention Description

One PF-07081532 20 mg tablet, administered orally

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration (Cmax)

Time Frame

up to day 7

Title

AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).

Time Frame

up to day 7

Title

AUCinfu= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for unbound drug

Time Frame

up to day 7

Title

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Time Frame

up to day 7

Title

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClastu) for unbound drug.

Time Frame

up to day 7

Title

Cmax, u is the highest measured unbound plasma concentration during the dosing interval.

Time Frame

up to day 7

Title

Fraction of unbound drug in plasma; Cu/C where Cu represents unbound concentration and C represents total concentration

Time Frame

day 1

Secondary Outcome Measure Information:

Title

Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

Time Frame

Baseline to Day 29

Title

Number of Participants With Treatment Emergent Clinically Significant Clinical Laboratory Abnormalities

Time Frame

Baseline to Day 7

Title

Number of Participants With Treatment Emergent Clinically Significant Change from Baseline in Vital Signs Abnormalities

Time Frame

Baseline to Day 7

Title

Number of Participants With Treatment emergent Clinically Significant Abnormal ECG

Time Frame

Baseline to Day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Stable renal function (for participants not on dialysis) defined as ≤25% difference between 2 measurements of BSA-unnormalized eGFR A prior diagnosis of T2DM with an HbA1c ≥6% and ≤10.5% Women may be of child-bearing potential BMI of 17.5 to 45.4 kg/m2 NORMAL FUNCTION (GROUP 1): Normal renal function (mean eGFR ≥90 mL/min) based on an average of measures from Screening visits S1 and S2 (eGFR should be calculated using the 2021 CKD EPI Scr-Scys combined equation: Demographically comparable to participants with impaired renal function at Screening A body weight within ±15 kg of the mean body weight of the pooled renal impairment groups (Groups 2, 3 and 4) An age within ±10 years of the mean age of the pooled renal impairment groups (Groups 2, 3 and 4) Attempts will be made to ensure that the male to female distribution in Group 1 is comparable to that in the pooled renal impairment groups (Groups 2, 3 and 4). Exclusion Criteria: Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes, or history of diabetic ketoacidosis. History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II-IV heart failure, or transient ischemic attack within 3 months of Screening Personal or family history of MTC or MEN2, or participants with suspected MTC per the investigator's judgement. History of acute pancreatitis within 6 months before Screening or any history of chronic pancreatitis. Urinary incontinence. Participants with acute renal disease. Renal allograft recipients. Participants who have previously received a kidney, liver, or heart transplant.

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

Genesis Clinical Research, LLC

City

Tampa

State/Province

Florida

ZIP/Postal Code

33603

Country

United States

Facility Name

Prism Research LLC dba Nucleus Network

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55114

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=C3991007

Description

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Learn more about this trial

A Clinical Trial of the Study Medicine (PF-07081532) in People With Diabetes and Kidney Dysfunction

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