A Study of Carbamazepine (CBZ) and MK-8527 in Healthy Adult Participants (MK-8527-012)
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT06893081
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 16
- Starts
- 2025-04-28
- Expected to finish
- 2025-07-17
- Last updated by the study team
- 2025-07-29
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Celerion ( Site 0001) — Tempe, Arizona, United States
Full record on ClinicalTrials.gov
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