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

Description

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.

Conditions

Healthy

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Study Overview

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Study Details

Study overview

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.

An Open-label, Phase 1 Study to Characterize the Effects of a Strong CYP3A4 Inducer on the Pharmacokinetics of MK-8527 in Healthy Adult Participants

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

Condition
Healthy
Intervention / Treatment

-

Contacts and Locations

Tempe

Celerion ( Site 0001), Tempe, Arizona, United States, 85283

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * 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.

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2025-07-11