Drug Interaction Study in Healthy Subjects
Trial Summary
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, your medical history and current medications will be reviewed during the screening period to determine eligibility.
What data supports the idea that Drug Interaction Study in Healthy Subjects is an effective drug?
The available research does not provide direct evidence that the Drug Interaction Study in Healthy Subjects, involving carbamazepine, is an effective treatment for its intended use. Instead, the studies focus on how carbamazepine interacts with other drugs, like ritonavir and efavirenz, which can affect its concentration in the body. These interactions can lead to side effects or changes in how well the drug works. Therefore, while the studies highlight the importance of monitoring drug interactions, they do not specifically support the effectiveness of carbamazepine as a treatment.12345
What safety data is available for carbamazepine?
The safety data for carbamazepine includes studies on its bioequivalence and pharmacokinetics. A study comparing generic (Epitol) and brand name (Tegretol) carbamazepine found them to be clinically equivalent in efficacy and bioequivalence. However, there have been reports of carbamazepine toxicity due to generic substitution, with cases of increased serum concentrations leading to toxicity. Additionally, drug interactions, such as with erythromycin and ketoconazole, can lead to carbamazepine neurotoxicity. These findings highlight the importance of monitoring serum levels and being cautious of drug interactions.678910
Is Carbamazepine, also known as Ibuzatrelvir, a promising drug in the study of drug interactions in healthy subjects?
What is the purpose of this trial?
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 healthyThe 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.
Research Team
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Eligibility Criteria
This trial is for healthy adults who are not able to have children. Participants must be at least 18 years old and will undergo a screening process to confirm their health status before joining the study. They'll need to stay in the clinic for 18 days.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive a single oral dose of ibuzatrelvir 600 mg
Treatment Period 2
Participants receive carbamazepine BID titrated from 100 mg to 300 mg over 15 days with a single ibuzatrelvir 600 mg dose coadministered on day 15
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Carbamazepine
- Ibuzatrelvir
Carbamazepine is already approved in United States, European Union, Canada, Japan for the following indications:
- Seizure disorders
- Trigeminal neuralgia
- Bipolar disorder
- Epilepsy
- Trigeminal neuralgia
- Mania associated with bipolar disorder
- Seizure disorders
- Trigeminal neuralgia
- Bipolar disorder
- Epilepsy
- Trigeminal neuralgia
- Mania associated with bipolar disorder
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University