Clinical trial NCT06893081: A Study of Carbamazepine (CBZ) and MK-8527 in Healthy Adult Participants (MK-8527-012)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-03-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of MK-8527
timeFrame: Predose and at designated timepoints (up to 168 hours postdose)
measure: Area Under the Concentration-Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of MK-8527
timeFrame: Predose and at designated timepoints (up to 168 hours postdose)
measure: Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-8527
timeFrame: Predose and at designated timepoints (up to 24 hours postdose)
measure: Area Under the Concentration-Time Curve from 0 to 168 hours (AUC0-168) of MK-8527
timeFrame: Predose and at designated timepoints (up to 168 hours postdose)
measure: Maximum Observed Plasma Concentration (Cmax) of MK-8527
timeFrame: Predose and at designated timepoints (up to 168 hours postdose)
measure: Time to Maximum Observed Plasma Concentration (Tmax) of MK-8527
timeFrame: Predose and at designated timepoints (up to 168 hours postdose)
measure: Apparent Terminal Half-Life (t1/2) of MK-8527
timeFrame: Predose and at designated timepoints (up to 168 hours postdose)
measure: Apparent Clearance (CL/F) of MK-8527
timeFrame: Predose and at designated timepoints (up to 168 hours postdose)
measure: Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527
timeFrame: Predose and at designated timepoints (up to 168 hours postdose)
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 60 days
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 30 days
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion ( Site 0001)
state: Arizona
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: