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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: MK-8527; Drug: CBZ

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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
  • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: MK-8527; Oral Tablet; Drug: CBZ; Oral Extended-release Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of MK-8527	Blood samples will be collected to determine the AUC0-inf of MK-8527 in plasma	Predose and at designated timepoints (up to 168 hours postdose)
Area Under the Concentration-Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of MK-8527	Blood samples will be collected to determine the AUC0-last of MK-8527 in plasma	Predose and at designated timepoints (up to 168 hours postdose)
Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-8527	Blood samples will be collected to determine the AUC0-24 of MK-8527 in plasma	Predose and at designated timepoints (up to 24 hours postdose)
Area Under the Concentration-Time Curve from 0 to 168 hours (AUC0-168) of MK-8527	Blood samples will be collected to determine the AUC0-168 of MK-8527 in plasma	Predose and at designated timepoints (up to 168 hours postdose)
Maximum Observed Plasma Concentration (Cmax) of MK-8527	Blood samples will be collected to determine the Cmax of MK-8527 in plasma	Predose and at designated timepoints (up to 168 hours postdose)
Time to Maximum Observed Plasma Concentration (Tmax) of MK-8527	Blood samples will be collected to determine the Tmax of MK-8527 in plasma	Predose and at designated timepoints (up to 168 hours postdose)
Apparent Terminal Half-Life (t1/2) of MK-8527	Blood samples will be collected to determine the t1/2 of MK-8527 in plasma	Predose and at designated timepoints (up to 168 hours postdose)
Apparent Clearance (CL/F) of MK-8527	Blood samples will be collected to determine the CL/F of MK-8527 in plasma	Predose and at designated timepoints (up to 168 hours postdose)
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527	Blood samples will be collected to determine the Vz/F of MK-8527 in plasma	Predose and at designated timepoints (up to 168 hours postdose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experience an Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.	Up to approximately 60 days
Number of Participants Who Discontinue Study Treatment Due to an AE	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.	Up to approximately 30 days

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2025
• Primary Completion (Actual): June 19, 2025
• Study Completion (Actual): July 17, 2025

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 8527-012; MK-8527-012 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No