Evaluating how MK-1084 is processed in healthy adults
A Two-Part Study to Determine Bioequivalence Between the MK-1084 Film-Coated Tablet and Oral-Compressed Tablet and the Effect of Food on the Single-Dose Pharmacokinetics of the MK-1084 Film-Coated Tablet in Healthy Adult Participants
PHASE1 · Merck Sharp & Dohme LLC · NCT06942741
This study is testing how a new drug called MK-1084 is absorbed in healthy adults by comparing two types of tablets and seeing how food affects its absorption.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC (industry) |
| Locations | 1 site (Tempe, Arizona) |
| Trial ID | NCT06942741 on ClinicalTrials.gov |
What this trial studies
This study consists of two parts aimed at understanding the pharmacokinetics of MK-1084 in healthy individuals. In Part 1, researchers will compare the absorption and blood concentration levels of MK-1084 when administered as two different types of oral tablets. Part 2 will investigate how food intake affects the drug's absorption by administering it on an empty stomach versus after a meal. The study is designed to gather important data on the drug's behavior in the body, which is crucial for future development.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults with a body mass index between 18.0 and 32.0 kg/m².
Not a fit: Patients with significant medical or psychiatric conditions, a history of cancer, or positive results for certain viral infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the optimal formulation and administration of MK-1084, enhancing its effectiveness for future therapeutic use.
How similar studies have performed: While this specific approach is focused on MK-1084, similar pharmacokinetic studies have shown success in optimizing drug formulations and administration methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: - Has a body mass index ≥18.0 and ≤32.0 kg/m\^2 Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a history or presence of a clinically significant medical or psychiatric condition or disease * Has a history of cancer (malignancy) * Has positive results for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus
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.
Conditions: Healthy