Status:
COMPLETED
A Study of Carbamazepine (CBZ) and MK-8527 in Healthy Adult Participants (MK-8527-012)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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
- 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
- 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.
Key Trial Info
Start Date :
April 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06893081
Start Date
April 28 2025
End Date
July 17 2025
Last Update
July 29 2025
Active Locations (1)
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1
Celerion ( Site 0001)
Tempe, Arizona, United States, 85283