A Study to Learn if Study Medicines Called Cyclosporine and Clarithromycin Affect How the Body Processes the Other Study Medicine Called PF-07328948 in Healthy Adults

Phase 1

Active, not recruiting

• Conditions: Healthy Adults
• Interventions: Drug: PF-07328948; Drug: cyclosporine; Drug: clarithromycin

• Registration Number: NCT06837259
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to learn about the effect of cyclosporine, an immunosuppressant (medicine that suppresses the immune system), on the pharmacokinetics (PK) of PF-07328948 in healthy participants (Part A). The study may also estimate the effect of clarithromycin, an antibiotic, on the PK of PF-07328948 in healthy participants (Part B is optional).

This study is seeking participants who:

* are 18 years of age or older

* are male or female who are not of childbearing potential

* are healthy (do not have a disease) The study will consist of two parts - Part A and Part B.

Part A will consist of two treatments:

* one dose of PF-07328948 solution to be taken by mouth on day 1.

* one cyclosporine 600 mg capsule taken together with a dose of PF-07328948 solution by mouth on day 12.

Before study Part A starts, all participants will go through a screening process which may last for a period of up to 28 days. During this period, the participant's medical history and past and current medications will be reviewed. A series of tests will also be performed.

If the participants meet all required criteria and want to continue, they will be brought into the study clinic to stay overnight for 17 days. During this period, the experiences of participants receiving the study medicine will be examined. Samples for laboratory assessments will be collected. Vital signs and medical assessments will also be performed. This will help determine if it is safe to take the study medicines together and what happens to these medicines in one's body (called PK assessment). After Part A, participants will be discharged from the clinic.

Based upon the results of Part A, study participants may proceed to Part B. If Part B occurs, participants will return to the study clinic and remain in the clinic for 8 days. There will be a gap of at least 7 days between Part A and Part B.

Part B will consist of a third treatment:

- clarithromycin 500 mg tablet to be taken 2 times a day for 6 days. On day 4, the tablet will be taken together by mouth with a dose of PF-07328948 solution.

During this period, similar laboratory and medical assessments as done in Part A will occur. After Part B, participants will be discharged from the clinic.

The participant will be contacted for a follow up visit by telephone about 30 days after final treatment. This is to check up on how the participant is doing and to conclude the study. If only Part A occurs, a participant will be in the study about 44 days. If Part B occurs, a participant will be in the study for about 64 days.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-14
• Study First Posted: 2025-02-20
• Study Start: 2025-03-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Primary Completion: 2025-06-11
• Study Completion: 2025-06-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Period 1	PF-07328948	PF-07328948
Period 2	PF-07328948	cyclosporine and PF-07328948
Period 2	cyclosporine	cyclosporine and PF-07328948
Period 3 (optional)	PF-07328948	clarithromycin and PF-07328948
Period 3 (optional)	clarithromycin	clarithromycin and PF-07328948

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) of PF-07328948	Hour 0, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07328948	Hour 0, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 post-dose	if data permits
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07328948	Hour 0, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 post-dose	If AUCinf cannot be completed

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)	Baseline (Day 0) up to 35 days after last dose of study medication
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities	Baseline up to Day 18 (Part A) or up to Day 35 (optional Part B)
Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate	Baseline up to Day 18 (Part A) or up to Day 35 (optional Part B)
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings	Baseline up to Day 18 (Part A) or up to Day 35 (optional Part B)

Trial Locations

Locations (1)

Pfizer Clinical Research Unit - Brussels; 🇧🇪 Brussels, Bruxelles-capitale, Région DE, Belgium