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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how carbamazepine affects the body's processing of another drug, PF-07220060, in healthy adults. It consists of two parts: first, researchers will observe how the body handles PF-07220060 alone, and then how it is processed after several days of carbamazepine use. Healthy adults with a body mass index (BMI) between 17.5 and 30.5 and weighing more than 110 pounds may be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that carbamazepine is often used to treat seizures and other conditions. It is usually well-tolerated but may cause side effects like dizziness or nausea and can alter the effects of other drugs in the body.

PF-07220060 is a newer drug under study to assess its safety and effects. Previous studies found it can cause common side effects, such as a low white blood cell count, diarrhea, and nausea, though serious side effects have been rare.

The current study is in its early stages, with safety being closely monitored. In these initial trials, researchers focus on understanding possible side effects and how the body processes the drug. This helps determine the treatment's safety for further research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore how PF-07220060 interacts with carbamazepine, a common antiepileptic drug. Unlike the standard of care, which focuses on managing symptoms, this trial aims to understand drug interactions that could optimize future treatments. PF-07220060 is unique in its potential to influence metabolic pathways differently when combined with carbamazepine, offering insights into more personalized medication strategies. This could lead to improved effectiveness and safety profiles for patients requiring multiple medications.

What evidence suggests that this trial's treatments could be effective?

Research has shown that carbamazepine, a drug that affects the processing of other drugs in the body, can reduce PF-07220060 levels by 63.5%. This trial will examine how the body processes PF-07220060 both when taken alone and after multiple doses of carbamazepine. Previous studies have found PF-07220060 to be safe and effective when combined with other treatments for certain cancers, such as HR-positive, HER2-negative metastatic breast cancer. However, its safety and effectiveness when used alone remain under investigation. This trial aims to better understand the interaction between these two drugs. ^{1 2 5 6 7}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11823298/

The effect of carbamazepine, a strong CYP3A inducer, on the ... Zongertinib exposure was reduced by 63.5% when coadministered with the strong CYP3A inducer, carbamazepine.

2. ichgcp.net ichgcp.net/clinical-trials-registry/NCT06897683

Clinical Trial on PF-07220060, Carbamazepine ER Tablet The purpose of this study is to learn how carbamazepine changes how the body processes PF-07220060 in the body of healthy adults.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06897683?term=CARBAMAZEPINE&rank=3

A Study to Learn if the Study Medicine Called ... The purpose of this study is to learn how carbamazepine changes how the body processes PF-07220060 in the body of healthy adults.

4. withpower.com withpower.com/trial/phase-1-healthy-adults-2-2025-6d1d7

Carbamazepine for Drug Interaction Study in Healthy Adults 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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39727284/

The effect of carbamazepine, a strong CYP3A inducer, on ... Zongertinib exposure was reduced by 63.5% when coadministered with the strong CYP3A inducer, carbamazepine.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06897683

NCT06897683 | A Study to Learn if the Study Medicine ... 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 ...

7. sigma.larvol.com sigma.larvol.com/ott.php?e1=409215&phase=1&sourcepg=TZ

Online Trial Tracker NCT06847464: A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the Pharmacokinetics and Safety ...