Carbamazepine for Drug Interaction Study in Healthy Adults

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must be taking: Carbamazepine

Must not be taking: CYP3A4 inducers, UGT2B7 inhibitors

Disqualifiers: HLA-B*1502, HLA-A*3101, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 240

14 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to learn how carbamazepine changes how the body processes PF-07220060 in the body of healthy adults. This study will happen in 2 periods. The purpose of Period 1 of the study is to understand how the medicine is changed and eliminated from the body after it is taken) and safety of a single dose of PF-07220060. The purpose of Period 2 of the study is to understand how the medicine is changed and eliminated from the body after it is taken and safety of a single dose of PF-07220060 following multiple days dosing carbamazepine twice a day. Multiple blood samples will be collected in each period up to 120 hours after the PF-07220060 dose in order to measure the amount of PF-07220060 in the blood. On Day 1 in Period 1, a single oral dose of PF-07220060 will be administered with food. Period 2 will begin following the last blood sample collection in Period 1. Carbamazepine will be dosed in Period 2 at 100 mg twice a day on Days 1, 2, and 3, and then, will increase to 200 mg twice a day on Days 4, 5, 6, and 7, and will eventually increase to and be maintained at 300 mg twice a day for the rest of Period 2 from Day 8 to Day 18. On Day 14 in Period 2, a single oral dose of PF-07220060 will be administered.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any prescription or nonprescription drugs, dietary, and herbal supplements at least 7 days or 5 half-lives before the trial starts. Also, you cannot use medications that strongly affect certain liver enzymes up to 56 days before the trial.

Is carbamazepine generally safe for humans?

Carbamazepine is generally considered safe for humans, but it can cause side effects like skin reactions, liver issues, and blood problems. These side effects are usually rare and often occur when starting or increasing the dose. ^{1 2 3 4 5}

How does the drug carbamazepine differ from other treatments?

Carbamazepine is unique because it not only treats epilepsy and certain types of pain but also has a complex interaction profile with other drugs due to its ability to induce and be affected by liver enzymes that metabolize many medications. This means it can change how other drugs work in the body, which is different from many other treatments that do not have such extensive drug interaction potential. ^{1 2 3 6 7}

What data supports the effectiveness of the drug Carbamazepine?

Carbamazepine is an effective drug for treating epilepsy and certain types of nerve pain, and it has been used for mood disorders. It is well-known for its ability to manage seizures and has cognitive and behavioral benefits compared to other similar drugs. ^{1 2 3 8 9}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for healthy adults who want to help understand how the body processes a medicine called PF-07220060, both alone and when taken with another drug called Carbamazepine. Specific eligibility details are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

Body mass index (BMI) of 17.5-30.5 kg/m2; and a total body weight >50 kg (110 lb)

Evidence of a personally signed and dated ICD indicating that the participant has been informed of all pertinent aspects of the study

I am willing and able to follow all study requirements.

Exclusion Criteria

I carry the HLA-B*1502 or HLA-A*3101 gene related to severe skin reactions.

I haven't taken any drugs or supplements within 7 days or 5 half-lives before starting the study treatment.

I haven't taken strong drugs affecting liver enzymes recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Period 1

Single dose of PF-07220060 administered with food to understand pharmacokinetics and safety

1 day

Multiple blood samples collected up to 120 hours post-dose

Period 2

Single dose of PF-07220060 administered after multiple doses of carbamazepine to understand pharmacokinetics and safety

18 days

Multiple blood samples collected up to 120 hours post-dose

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Carbamazepine
• PF-07220060

Trial Overview The study tests how Carbamazepine affects the processing of PF-07220060 in the body. It's divided into two periods: one where PF-07220060 is given alone, and another where it's combined with increasing doses of Carbamazepine over several days.

How Is the Trial Designed?

Group I: Period 2 Experimental Treatment 2 Interventions

Single dose PF-07220060 given after multiple doses of carbamazepine

Group II: Period 1 Experimental Treatment 1 Intervention

Single dose PF-07220060 alone

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

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbamazepine drug interactions. Baciewicz, AM.[2019]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Clinically significant pharmacokinetic drug interactions with carbamazepine. An update. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Risk-benefit assessment of carbamazepine in children. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Carbamazepine in psychiatry: a review. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Carbamazepine drug interactions. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Investigation of phenobarbital-carbamazepine-valproic acid interactions using population pharmacokinetic analysis for optimisation of antiepileptic drug therapy: an overview. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Time-dependent inhibition of carbamazepine metabolism by piperine in anti-epileptic treatment. [2019]

7. India pubmed.ncbi.nlm.nih.gov

Carbamazepine-induced hepato-splenomegaly with erythematous rashes in a child. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Carbamazepine overdose after exposure to simethicone: a case report. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of the CYP3A4 and CYP2B6 Inducer Carbamazepine and Its Drug-Drug Interaction Potential: A Physiologically Based Pharmacokinetic Modeling Approach. [2021]