NCT05510245

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	PF-07081532	One PF-07081532 20 mg tablet, administered orally

Timeline

• Start date: 2022-08-29
• Primary completion: 2023-07-20
• Completion: 2023-07-20
• First posted: 2022-08-22
• Last updated: 2024-11-05
• Results posted: 2024-11-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study