Evaluating different forms of enlicitide in healthy adults
A Clinical Study to Evaluate the Relative Bioavailability of Enlicitide Formulations in Healthy Adult Participants
This study is testing different forms of enlicitide in healthy adults to see how they are absorbed and processed in the body over time.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 1 site (Tempe, Arizona) |
| Trial ID | NCT06880874 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to understand how various formulations of enlicitide medications behave in the bodies of healthy adult participants over time. Researchers will administer different formulations of enlicitide and measure the concentration of the drug in the participants' systems at various intervals. The study is designed to gather data on the pharmacokinetics of enlicitide, which could inform future therapeutic applications. Participants must meet specific health criteria to ensure accurate results.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 with a BMI between 18 and 32 who are non-smokers.
Not a fit: Patients with a history of gastrointestinal diseases, cancer, or viral infections such as HIV or hepatitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of enlicitide's pharmacokinetics, leading to improved formulations for future therapeutic use.
How similar studies have performed: While this study focuses on a specific formulation of enlicitide, similar pharmacokinetic studies have shown success in understanding drug behavior in healthy populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior * Has body mass index (BMI) ≥18 kg/m\^2 and ≤32 kg/m\^2 Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has history of gastrointestinal disease which may affect food and drug absorption or has had a gastric bypass or similar surgery * Has history of cancer (malignancy) * Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
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.