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

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: MK-8527; Drug: CBZ

• Registration Number: NCT06893081
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-18
• Study First Posted: 2025-03-25
• Study Start: 2025-04-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-06-19
• Study Completion: 2025-07-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MK-8527 + CBZ	MK-8527	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.
MK-8527 + CBZ	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experience an Adverse Event (AE)	Up to approximately 60 days	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.
Number of Participants Who Discontinue Study Treatment Due to an AE	Up to approximately 30 days	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.

Trial Locations

Locations (1)

Celerion ( Site 0001); 🇺🇸 Tempe, Arizona, United States