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The purpose of this study is to estimate the effect of carbamazepine, a strong CYP3A4 inducer, on the pharmacokinetics (PK) of ibuzatrelvir in healthy participants.
This study is seeking participants who:
The study will consist of two treatments: (1) a single oral dose of ibuzatrelvir 600 mg alone in Period 1 and (2) carbamazepine q12h (BID) titrated from 100 mg to 300 mg over 15 days with a single ibuzatrelvir 600 mg dose coadministered on day 15 in Period 2. All treatments will be taken by mouth.
All participants will remain in the study clinic for 18 days for safety review, laboratory collections, and to collect samples for PK.
All participants selected in the study will be required to go through a screening period up to 28 days. A screening period is the time during which a few participants are examined to see whether they are fit for the study. During this period, the participant's medical history and past and current medications will be reviewed. A series of tests will also be performed to see if they are good to be selected for the study. If the participant meets all required criteria and are interested in continuing, the participant will be brought into the study clinic to stay overnight for 18 days. About 28 to 35 days after discharge following the final treatment, the participant will be contacted for a follow up visit either in person or by telephone. This is to check up on how the participant is doing and to conclude the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Experimental | ibuzatrelvir single oral dose on Day 1. |
|
| Period 2 | Experimental | carbamazepine BID oral doses on Day 1-15. ibuzatrelvir single oral dose on Day 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibuzatrelvir | Drug | 2x 300 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of ibuzatrelvir | Hour 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 post-dose in each period | |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of ibuzatrelvir | if data permits | Hour 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 post-dose in each period |
| Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) ofibuzatrelvir | Hour 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 post-dose in each period |
| 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 Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
-Male participants and female participants who are not of childbearing potential who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate and standard 12 lead ECG
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
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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 - New Haven | New Haven | Connecticut | 06511 | United States |
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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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open-label, 2-period, fixed sequence
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| carbamazepine ER | Drug | 100 mg BID (Day 1-3) 200 mg BID (Day 4-7) 300 mg BID (Day 8-15) |
|
| Baseline up to Day 18 |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Baseline up to Day 18 |