NCT06655311CompletedPhase 1
A Study of Enlicitide Chloride (MK-0616) in Healthy Participants and Participants Taking Statins (MK-0616-012)
Multiple-Rising Dose Clinical Study to Evaluate the Safety and Pharmacokinetics of MK-0616 in Healthy Participants and in Male and Female Participants Taking Statins
Source: ClinicalTrials.gov · Last updated 23 Oct 2024
Brief summary (registry, in English)
The goal of this study is to learn what happens to different doses of enlicitide chloride over time in the body of healthy participants and participants taking statins, a group of medicines used to reduce the levels of high cholesterol in the bloodstream. The researchers want to learn about the safety of enlicitide chloride when administered at high doses.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (actual)
- First submitted
- 21 Oct 2024
- Start date
- 30 Sept 2022
- Primary completion date
- 2 Jan 2024
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT06655311
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 56
- From 30 Sept 2022 to the primary completion date, 2 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major (including stroke and chronic seizures) abnormalities or diseases
- Has a history of cancer
Other
- The key exclusion criteria include but are not limited to the following:
Who the study is looking for
- The key inclusion criteria include but are not limited to the following:
- Is in good health based on medical history, physical examination, vital signs (VS) measurements, electrocardiograms (ECGs), and laboratory safety tests performed before randomization
- Has a body mass index (BMI)≥18 and ≤32 kg/m\^2
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Altasciences Clinical Kansas, Inc. (Site 0002) Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.