12 Participants Needed

Drug Interaction Study in Healthy Subjects

Recruiting at 1 trial location
PC
Overseen ByPfizer CT.gov Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Pfizer
Must be taking: Carbamazepine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Carbamazepine is a promising drug because it is commonly used to treat seizures and nerve pain. It can affect how other drugs work in the body, which is important for understanding drug interactions.12579

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

PC

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

I am healthy with normal medical exams, lab tests, blood pressure, pulse, and ECG results.

Exclusion Criteria

I don't have any serious ongoing health issues apart from untreated seasonal allergies.
Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Participants with ANY of the following abnormalities in clinical laboratory tests at screening and prior to dosing in each period, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: ALT, AST, Bilirubin β‰₯1.5 x ULN. Participants with an elevated total bilirubin consistent with Gilberts Disease may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≀ ULN.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 28 days

Treatment Period 1

Participants receive a single oral dose of ibuzatrelvir 600 mg

1 day
1 visit (in-clinic)

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

15 days
In-clinic stay for 18 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 to 35 days post-discharge
1 visit (in-person or telephone)

Treatment Details

Interventions

  • Carbamazepine
  • Ibuzatrelvir
Trial Overview The study tests how carbamazepine, which affects drug processing in the body, influences ibuzatrelvir levels. It involves two treatments: one with just ibuzatrelvir and another combining it with gradually increased doses of carbamazepine.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Period 2Experimental Treatment2 Interventions
carbamazepine BID oral doses on Day 1-15. ibuzatrelvir single oral dose on Day 14.
Group II: Period 1Experimental Treatment1 Intervention
ibuzatrelvir single oral dose on Day 1.

Carbamazepine is already approved in United States, European Union, Canada, Japan for the following indications:

πŸ‡ΊπŸ‡Έ
Approved in United States as Tegretol for:
  • Seizure disorders
  • Trigeminal neuralgia
  • Bipolar disorder
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Approved in European Union as Carbamazepine for:
  • Epilepsy
  • Trigeminal neuralgia
  • Mania associated with bipolar disorder
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Approved in Canada as Tegretol for:
  • Seizure disorders
  • Trigeminal neuralgia
  • Bipolar disorder
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Approved in Japan as Carbamazepine for:
  • Epilepsy
  • Trigeminal neuralgia
  • Mania associated with bipolar disorder

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

The concurrent administration of ritonavir (RTV) and carbamazepine (CBZ) in a patient with HIV and epilepsy led to dangerously elevated levels of CBZ, resulting in symptoms like vomiting, vertigo, and liver dysfunction.
Discontinuing RTV and adjusting the CBZ dosage successfully normalized CBZ levels and resolved the adverse symptoms, highlighting the importance of monitoring drug interactions, especially since RTV inhibits the liver enzymes that metabolize CBZ.
Potential interaction between ritonavir and carbamazepine.Kato, Y., Fujii, T., Mizoguchi, N., et al.[2019]
Carbamazepine (CBZ) can significantly affect the metabolism of other drugs, potentially leading to clinically important drug interactions, as it may accelerate the metabolism of medications like phenytoin and warfarin.
Conversely, other drugs such as phenytoin and erythromycin can also influence the metabolism of CBZ, highlighting the need for careful monitoring of drug interactions in patients taking CBZ.
Carbamazepine drug interactions.Baciewicz, AM.[2019]
Coadministration of efavirenz and carbamazepine in healthy adults significantly reduced the exposure of both drugs, indicating a pharmacokinetic interaction that could affect their effectiveness.
Specifically, efavirenz exposure decreased by about 36% and carbamazepine exposure decreased by about 27%, while the metabolite carbamazepine-10,11-epoxide showed minimal change, suggesting that careful monitoring may be needed when these medications are used together.
Pharmacokinetic interaction between efavirenz and carbamazepine after multiple-dose administration in healthy subjects.Ji, P., Damle, B., Xie, J., et al.[2020]

References

Potential interaction between ritonavir and carbamazepine. [2019]
Carbamazepine drug interactions. [2019]
Pharmacokinetic interaction between efavirenz and carbamazepine after multiple-dose administration in healthy subjects. [2020]
Pharmacokinetic-pharmacodynamic consequences and clinical relevance of cytochrome P450 3A4 inhibition. [2022]
Lack of interaction between cimetidine and carbamazepine. [2019]
Therapeutic bioequivalency study of brand name versus generic carbamazepine. [2019]
Reanalysis of carbamazepine and carbamazepine-epoxide pharmacokinetics after multiple dosing of extended release formulation. [2015]
Carbamazepine toxicity resulting from generic substitution. [2019]
Multiple drug interaction across medical specializations. [2021]
Comparative bioavailability study of a conventional and two controlled release oral formulations of Tegretol (carbamazepine)--200 mg. [2013]
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