Actively Recruiting
A Clinical Study to Evaluate the Relative Bioavailability of Enlicitide and Rosuvastatin Tablets Compared to Their Separate Use in Healthy Adults
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-28
60
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two medicines, enlicitide and rosuvastatin, in healthy adults to understand how much of each drug is present in the body over time. The study compares these medicines when taken separately versus combined into one tablet. This phase 1 trial aims to learn about the relative bioavailability of these drugs to improve medication options. Participants will receive either a single dose of enlicitide and rosuvastatin tablets taken together or a single dose of a combined tablet (MK-0616A or its formulation B). The study has two parts, with each part involving these different dosing methods to compare how the body processes the drugs. During the study, blood samples will be collected before dosing and at specific times up to 168 hours after to measure drug levels, including total exposure and maximum concentration. Participants will be monitored for any side effects for up to approximately 9 weeks, with treatment discontinuation tracked if side effects occur. The total participation time varies based on the dosing schedule and follow-up assessments.
CONDITIONS
Brief Title
A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Medically healthy with no significant medical history
- Non-smoker who has not used nicotine or tobacco products for at least 3 months
- Age between 18 and 55 years
You will not qualify if you...
- Unable or unwilling to stop using any drugs, including prescription, non-prescription medications, herbal remedies, or vitamin supplements starting 14 days before study entry
- Female participant of childbearing potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey: What to Expect
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 days
Participants receive single oral doses of the study drugs in two parts, including enlicitide and rosuvastatin tablets either coadministered or as fixed dose combinations.
Multiple visits over approximately 8 days
Duration - Up to approximately 9 weeks
Participants are monitored for adverse events and safety up to approximately 9 weeks after dosing.
Periodic visits for safety monitoring
Trial Site Locations
Total: 1 location
1
Celerion ( Site 0001)
Tempe, Arizona, United States, 85283
Actively Recruiting
Research Team
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Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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