A Study to Investigate the Effects of Renal Impairment on the Pharmacokinetics of PF-07081532

• Status: Not yet recruiting
• Trial end date: 2023-10-25
• Target enrollment: 0
• Participant gender: All

Summary

A Study to Investigate the Effects of Renal Impairment on the Pharmacokinetics of PF-07081532, one 20 mg tablet administered orally.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

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.