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

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Conditions

Healthy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-28
Study Completion:2025-07-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06893081

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.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Is a healthy, adult, male or female of non-childbearing potential only, 18-55 years of age, inclusive
  2. * Is a continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior
  1. * Has a history or presence of:
  2. * Seizures (except for febrile seizure), or is at an increased risk for seizures
  3. * Family history of severe dermatologic reactions including toxic epidermal necrolysis and Stevens-Johnson syndrome
  4. * Clinically meaningful hematologic diseases, bone marrow disorders, or hematologic adverse reactions to other medications
  5. * Depression, unusual changes in mood or behavior or suicidal thoughts or behavior
  6. * Hypersensitivity reaction to anticonvulsant therapy (including phenytoin, primidone, and phenobarbital)
  7. * Clinically significant eye disease
  8. * Cardiac conduction disturbance, including second-and third-degree atrioventricular heart block
  9. * 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.

Contacts and Locations

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-28
Study Completion Date2025-07-17

Study Record Updates

Study Start Date2025-04-28
Study Completion Date2025-07-17

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy