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

NCT ID: NCT05510245

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-29
• Study Completion Date: 2023-07-20

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.

Conditions

Type 2 Diabetes; Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group 1

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

Group Type: EXPERIMENTAL

PF-07081532

Intervention Type: DRUG

One PF-07081532 20 mg tablet, administered orally

Group 2

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

Group Type: EXPERIMENTAL

PF-07081532

Intervention Type: DRUG

One PF-07081532 20 mg tablet, administered orally

Group 3

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

Group Type: EXPERIMENTAL

PF-07081532

Intervention Type: DRUG

One PF-07081532 20 mg tablet, administered orally

Group 4

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

Group Type: EXPERIMENTAL

PF-07081532

Intervention Type: DRUG

One PF-07081532 20 mg tablet, administered orally

Interventions

PF-07081532

One PF-07081532 20 mg tablet, administered orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Stable renal function (for participants not on dialysis) defined as ≤25% difference between 2 measurements of BSA-unnormalized eGFR

2. A prior diagnosis of T2DM with an HbA1c ≥6% and ≤10.5%

3. Women may be of child-bearing potential

4. BMI of 17.5 to 45.4 kg/m2

5. 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

1. Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes, or history of diabetic ketoacidosis.

2. 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

3. Personal or family history of MTC or MEN2, or participants with suspected MTC per the investigator's judgement.

4. History of acute pancreatitis within 6 months before Screening or any history of chronic pancreatitis.

5. Urinary incontinence.

6. Participants with acute renal disease.

7. Renal allograft recipients.

8. Participants who have previously received a kidney, liver, or heart transplant.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Genesis Clinical Research, LLC

Tampa, Florida, United States

Prism Research LLC dba Nucleus Network

Saint Paul, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C3991007

To obtain contact information for a study center near you, click here.

Other Identifiers

C3991007

Identifier Type: -

Identifier Source: org_study_id