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NCT06646042 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn If the Study Medicine Called Carbamazepine Changes How the Body Processes the Other Study Medicine Ibuzatrelvir in Healthy Adults
A Phase 1 study of Healthy, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT06646042: Completed Phase 1 study of Healthy, sponsored by Pfizer.
NCT06646042 is a Phase 1 study of Healthy that has completed, run by Pfizer. The registered enrollment target is 12 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06646042, a Phase 1 study of Healthy, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
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: * are male or female that are not of childbearing potential of 18 years of age or older * are examined to be healthy 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.
Conditions Studied
Interventions
- DRUG ibuzatrelvir
- DRUG carbamazepine ER
Study Locations (1)
Connecticut
- Pfizer Clinical Research Unit - New Haven - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-10-28 |
| Est. Completion | 2025-01-17 |
| Phase | Phase 1 |
What the finished NCT06646042 record still lists
NCT06646042 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which ibuzatrelvir is the first listed.
NCT06646042 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT06646042 about?
NCT06646042 is a clinical study titled "A Study to Learn If the Study Medicine Called Carbamazepine Changes How the Body Processes the Other Study Medicine Ibuzatrelvir in Healthy Adults". 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: * are male or female that are not of childbearing potential of 18 years of age or older * are...
What is the current status of trial NCT06646042?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2024-10-28. Estimated completion is 2025-01-17.
What conditions does trial NCT06646042 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT06646042?
The interventions under investigation include: ibuzatrelvir (DRUG), carbamazepine ER (DRUG).
Who is sponsoring clinical trial NCT06646042?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06646042 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06646042's enrollment target sits among peer trials
12 996th of 1090 higher than 61 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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