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

Last updated: June 3, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Not Recruiting

Phase

1

Condition

N/A

Treatment

MK-8527

CBZ

Clinical Study ID

NCT06893081
8527-012
MK-8527-012
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Inclusion criteria include, but are not limited to:

  • Is a healthy, adult, male or female of non-childbearing potential only, 18-55 yearsof age, inclusive

  • Is a continuous non-smoker who has not used nicotine- and tobacco-containingproducts for at least 3 months prior

Exclusion

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 epidermalnecrolysis and Stevens-Johnson syndrome

  • Clinically meaningful hematologic diseases, bone marrow disorders, orhematologic adverse reactions to other medications

  • Depression, unusual changes in mood or behavior or suicidal thoughts orbehavior

  • Hypersensitivity reaction to anticonvulsant therapy (including phenytoin,primidone, and phenobarbital)

  • Clinically significant eye disease

  • Cardiac conduction disturbance, including second-and third-degreeatrioventricular heart block

  • Shown to carry or be positive for HLA-A11:01, HLA-A31:01, HLA-B15:02,HLA-B15:08, HLA-B15:11, HLA-B15:21, HLA-B15:30, or HLA-B15:31 alleles.

Study Design

Total Participants: 16
Treatment Group(s): 2
Primary Treatment: MK-8527
Phase: 1
Study Start date:
April 28, 2025
Estimated Completion Date:
July 11, 2025

Connect with a study center

  • Celerion ( Site 0001)

    Tempe, Arizona 85283
    United States

    Site Not Available

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