Clinical trial NCT05510245: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Type 2 Diabetes
Renal Impairment
Keywords: Type 2 Diabetes
Renal impairment
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-08-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Maximum Observed Concentration (Cmax) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment
timeFrame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1
measure: Unbound Cmax (Cmax,u) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment
timeFrame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1
measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment
timeFrame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1
measure: Unbound AUCinf (AUCinf,u) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment
timeFrame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1
measure: Unbound Fraction (fu) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment
timeFrame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From time of administration of study treatment on Day 1 up to the end of the study (up to a maximum of 31 days post dose)
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Pre-dose, 72 and 144 hours post dose on Day 1
measure: Number of Participants With Vital Signs Data Meeting Pre-Defined Categorical Criteria
timeFrame: At admission on Day -1, pre-dose, and 24, 72, and 144 hours post the dose on Day 1
measure: Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Defined Categorical Criteria
timeFrame: Pre-dose, and 144 hours post the dose on Day 1
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Genesis Clinical Research, LLC
state: Florida
city: Saint Paul
country: United States
facility: Prism Research LLC dba Nucleus Network
state: Minnesota
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: