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

NCT06893081 | Completed Phase 1 FDA Drug

• 2 other identifiers: 8527-012MK-8527-012
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (2)

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 60 days

• Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 30 days

Study Arms (1)

MK-8527 + CBZ

EXPERIMENTAL

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; Drug: CBZ

Interventions

MK-8527 DRUG

Oral Tablet

MK-8527 + CBZ

CBZ DRUG

Oral Extended-release Capsule

MK-8527 + CBZ

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion ( Site 0001)

Tempe, Arizona, 85283, United States

Location

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: April 28, 2025
• Primary Completion: June 19, 2025
• Study Completion: July 17, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)