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

• ClinicalTrials.gov Identifier: NCT05510245
• Recruitment Status: Recruiting
• First Posted: August 22, 2022
• Last Update Posted: June 1, 2023
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes; Renal Impairment	Drug: PF-07081532	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 32 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: August 29, 2022
• Estimated Primary Completion Date: October 16, 2023
• Estimated Study Completion Date: October 16, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group 1; Participants without renal impairment will receive a single 20 mg dose of PF 07081532, administered orally	Drug: PF-07081532; One PF-07081532 20 mg tablet, administered orally
Experimental: Group 2; Participants with mild renal impairment will receive a single 20 mg dose of PF 07081532, administered orally	Drug: PF-07081532; One PF-07081532 20 mg tablet, administered orally
Experimental: Group 3; Participants with moderate renal impairment will receive a single 20 mg dose of PF 07081532, administered orally	Drug: PF-07081532; One PF-07081532 20 mg tablet, administered orally
Experimental: Group 4; Participants with severe renal impairment will receive a single 20 mg dose of PF 07081532, administered orally	Drug: PF-07081532; One PF-07081532 20 mg tablet, administered orally

Outcome Measures

Primary Outcome Measures :

1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: up to day 7 ]
2. AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). [ Time Frame: up to day 7 ]
3. AUCinfu= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for unbound drug [ Time Frame: up to day 7 ]
4. Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) [ Time Frame: up to day 7 ]
5. Area under the plasma concentration time-curve from zero to the last measured concentration (AUClastu) for unbound drug. [ Time Frame: up to day 7 ]
6. Cmax, u is the highest measured unbound plasma concentration during the dosing interval. [ Time Frame: up to day 7 ]
7. Fraction of unbound drug in plasma; Cu/C where Cu represents unbound concentration and C represents total concentration [ Time Frame: day 1 ]

Secondary Outcome Measures :

1. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: Baseline to Day 29 ]
2. Number of Participants With Treatment Emergent Clinically Significant Clinical Laboratory Abnormalities [ Time Frame: Baseline to Day 7 ]
3. Number of Participants With Treatment Emergent Clinically Significant Change from Baseline in Vital Signs Abnormalities [ Time Frame: Baseline to Day 7 ]
4. Number of Participants With Treatment emergent Clinically Significant Abnormal ECG [ Time Frame: Baseline to Day 7 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Pfizer CT.gov Call Center; 1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Locations

United States, Florida

Genesis Clinical Research, LLC; Recruiting

Tampa, Florida, United States, 33603

United States, Minnesota

Prism Research LLC dba Nucleus Network; Recruiting

Saint Paul, Minnesota, United States, 55114

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05510245
• Other Study ID Numbers: C3991007
• First Posted: August 22, 2022
• Last Update Posted: June 1, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:

Type 2 Diabetes; Renal impairment

Additional relevant MeSH terms:

Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases