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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-520126-11-00 | Registry Identifier | CTIS (EU) |
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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:
Part A will consist of two treatments:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Experimental | PF-07328948 |
|
| Period 2 | Experimental | cyclosporine and PF-07328948 |
|
| Period 3 (optional) | Experimental | clarithromycin and PF-07328948 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07328948 | Drug | single oral dose day 1 and day 12 (Part A) and day 4 (part B) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | if data permits | Hour 0, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 post-dose |
| Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07328948 | If AUCinf cannot be completed | Hour 0, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - Brussels | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| cyclosporine | Drug | 600 mg capsule day 12 (Part A) |
|
| clarithromycin | Drug | 500 mg tablets twice daily day 1 to day 6 (Part B) |
|
| 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) |
| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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