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OpenTrials
Completed

NCT Number: NCT06893081

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion ( Site 0001)

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MK-8527

Drug

Oral Tablet

CBZ

Drug

Oral Extended-release Capsule

Primary outcomes

  1. Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of MK-8527

    Time frame: 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

  2. Area Under the Concentration-Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of MK-8527

    Time frame: 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

  3. Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-8527

    Time frame: 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

  4. Area Under the Concentration-Time Curve from 0 to 168 hours (AUC0-168) of MK-8527

    Time frame: 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

  5. Maximum Observed Plasma Concentration (Cmax) of MK-8527

    Time frame: Predose and at designated timepoints (up to 168 hours postdose)

    Blood samples will be collected to determine the Cmax of MK-8527 in plasma

  6. Time to Maximum Observed Plasma Concentration (Tmax) of MK-8527

    Time frame: Predose and at designated timepoints (up to 168 hours postdose)

    Blood samples will be collected to determine the Tmax of MK-8527 in plasma

  7. Apparent Terminal Half-Life (t1/2) of MK-8527

    Time frame: 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

  8. Apparent Clearance (CL/F) of MK-8527

    Time frame: 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

  9. Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527

    Time frame: 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 outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: 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.

  2. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 25, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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