A Study to Investigate the Effects of Renal Impairment on the Pharmacokinetics of PF-07081532

• Sponsor: Pfizer (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05510245
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 13.6
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

A Study to Investigate the Effects of Renal Impairment on the Pharmacokinetics of PF-07081532, one 20 mg tablet administered orally.

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

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Sep 7, 2022
• Anticipated Primary Completion Date: Oct 25, 2023
• Anticipated Study Completion Date: Oct 25, 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) [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). [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 [up to day 7]

4. Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) [up to day 7]

5. Area under the plasma concentration time-curve from zero to the last measured concentration (AUClastu) for unbound drug. [up to day 7]

6. Cmax, u is the highest measured unbound plasma concentration during the dosing interval. [up to day 7]

7. Fraction of unbound drug in plasma; Cu/C where Cu represents unbound concentration and C represents total concentration [day 1]

Secondary Outcome Measures

1. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [Baseline to Day 29]

2. Number of Participants With Treatment Emergent Clinically Significant Clinical Laboratory Abnormalities [Baseline to Day 7]

3. Number of Participants With Treatment Emergent Clinically Significant Change from Baseline in Vital Signs Abnormalities [Baseline to Day 7]

4. Number of Participants With Treatment emergent Clinically Significant Abnormal ECG [Baseline to Day 7]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Genesis Clinical Research	Tampa	Florida	United States	33603

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

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

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Type 2

Study Results

No Results Posted as of Aug 22, 2022