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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05510245
Other study ID # C3991007
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


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
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