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
Verified date | December 2023 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Prism Research LLC dba Nucleus Network | Saint Paul | Minnesota |
United States | Genesis Clinical Research, LLC | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
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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