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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05510245
• Other study ID #: C3991007
• Status: Terminated
• Phase: Phase 1
• Start date: August 29, 2022
• Est. completion date: July 20, 2023

Study information

• Verified date: December 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: July 20, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Renal Impairment
• Renal Insufficiency
• Type 2 Diabetes

Intervention

Drug:
• PF-07081532
One PF-07081532 20 mg tablet, administered orally

Locations

Country	Name	City	State
United States	Prism Research LLC dba Nucleus Network	Saint Paul	Minnesota
United States	Genesis Clinical Research, LLC	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)		up to day 7
Primary	AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).		up to day 7
Primary	AUCinfu= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for unbound drug		up to day 7
Primary	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)		up to day 7
Primary	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClastu) for unbound drug.		up to day 7
Primary	Cmax, u is the highest measured unbound plasma concentration during the dosing interval.		up to day 7
Primary	Fraction of unbound drug in plasma; Cu/C where Cu represents unbound concentration and C represents total concentration		day 1
Secondary	Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)		Baseline to Day 29
Secondary	Number of Participants With Treatment Emergent Clinically Significant Clinical Laboratory Abnormalities		Baseline to Day 7
Secondary	Number of Participants With Treatment Emergent Clinically Significant Change from Baseline in Vital Signs Abnormalities		Baseline to Day 7
Secondary	Number of Participants With Treatment emergent Clinically Significant Abnormal ECG		Baseline to Day 7

External Links

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