Examining the effects of MK-8527 with and without Carbamazepine in healthy adults
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
This study is testing how the drug MK-8527 works in healthy adults, both on its own and when taken with Carbamazepine, to see how it behaves in the body and if it's safe.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 1 site (Tempe, Arizona) |
| Trial ID | NCT06893081 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate how the drug MK-8527 behaves in the body of healthy adult participants when administered alone and in combination with Carbamazepine (CBZ). It is an interventional Phase 1 trial that focuses on understanding the pharmacokinetics and safety profile of MK-8527. Participants will be healthy adults aged 18-55 who meet specific inclusion criteria and do not have a history of certain medical conditions. The study will help determine the effects of these medications on healthy individuals over time.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18-55 who are non-smokers and do not have a history of seizures or significant medical conditions.
Not a fit: Patients with a history of seizures, significant dermatologic reactions, or other serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and pharmacokinetics of MK-8527, potentially leading to improved treatment options for conditions requiring this medication.
How similar studies have performed: While this study is focused on a specific drug combination, similar studies have shown success in understanding drug interactions and pharmacokinetics in healthy populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tempe, Arizona
- Celerion ( Site 0001) — Tempe, Arizona, United States (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.