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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: MK-8527; Drug: CBZ

Study type: Interventional

Funder types: Industry

Identifiers

NCT06893081

MK-8527-012 (Other Identifier)

8527-012

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Inclusion criteria include, but are not limited to:

• 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

Exclusion criteria include, but are not limited to:

• 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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

MK-8527 + CBZ

Experimental group

Description:

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.

Treatment:

Drug: CBZ

Drug: MK-8527