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

Launched by MERCK SHARP & DOHME LLC · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "A Study of Carbamazepine (CBZ) and MK-8527 in Healthy Adult Participants," aims to understand how the medication MK-8527 behaves in the body of healthy adults. Researchers want to see how MK-8527 works on its own and how it interacts with another medication called carbamazepine (CBZ). This study is currently not recruiting participants, but it is looking for healthy adults aged 18 to 55 years who do not smoke and have not used tobacco products for at least three months.

To be eligible for this trial, participants should be generally healthy and cannot have a personal or family history of certain medical conditions, such as seizures or severe skin reactions to medications. Participants will undergo various assessments to ensure their health and safety during the study. While participating, individuals can expect to receive the medications and be monitored closely by the research team to track how their bodies respond. This is an important step in understanding how these medications work, which can help improve treatment options in the future.

Gender

ALL

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.