Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-25 @ 2:49 PM
Study NCT ID:
NCT06837259
Status:
COMPLETED
Last Update Posted:
2025-06-29
First Post:
2025-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effect of OATP Inhibition on the Single Dose Pharmacokinetics of PF-07328948 in Healthy Adult Participants.
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-520126-11-00 | REGISTRY | CTIS (EU) | View |