A Study of Carbamazepine (CBZ) and MK-8527 in Healthy Adult Participants (MK-8527-012)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-28

Study Completion Date

2025-07-17

Brief Summary

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The goal of this study is to learn what happens to MK-8527 in a healthy person's body over time when MK-8527 is given alone and with the medication CBZ.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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MK-8527 + CBZ

Treatment A (Period 1): Participants will receive a single dose of MK-8527 on Day 1.

Treatment B (Period 2): Participants will receive CBZ twice a day on Days 1 to 20 and a single dose of MK-8527 coadministered with the morning dose of CBZ on Day 14.

A washout period will separate Treatments A and B.

Group Type EXPERIMENTAL

MK-8527

Intervention Type DRUG

Oral Tablet

CBZ

Intervention Type DRUG

Oral Extended-release Capsule

Interventions

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MK-8527

Oral Tablet

Intervention Type DRUG

CBZ

Oral Extended-release Capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Is a healthy, adult, male or female of non-childbearing potential only, 18-55 years of age, inclusive
* Is a continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior

Exclusion Criteria

* Has a history or presence of:

* Seizures (except for febrile seizure), or is at an increased risk for seizures
* Family history of severe dermatologic reactions including toxic epidermal necrolysis and Stevens-Johnson syndrome
* Clinically meaningful hematologic diseases, bone marrow disorders, or hematologic adverse reactions to other medications
* Depression, unusual changes in mood or behavior or suicidal thoughts or behavior
* Hypersensitivity reaction to anticonvulsant therapy (including phenytoin, primidone, and phenobarbital)
* Clinically significant eye disease
* Cardiac conduction disturbance, including second-and third-degree atrioventricular heart block
* Shown to carry or be positive for HLA-A\*11:01, HLA-A\*31:01, HLA-B\*15:02, HLA-B\*15:08, HLA-B\*15:11, HLA-B\*15:21, HLA-B\*15:30, or HLA-B\*15:31 alleles.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes