A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Atorvastatin in Healthy Adult Participants (MK-0616-024)
Part of paid clinical trials in Lincoln, Nebraska.
- Sponsor
- Merck Sharp & Dohme LLC
- Study ID
- NCT06699355
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - 55 Years
- Healthy Volunteers
- Accepted
Interventions
- Enlicitide Decanoate — DRUGOral administration
- Atorvastatin — DRUGOral administration
Study Details
The goal of this study is to learn what happens to enlicitide decanoate and atorvastatin in a healthy person's body over time. Researchers want to learn what happens to enlicitide decanoate in the body when it is given with and without another medicine called atorvastatin and what happens to atorvastatin in the body when it is given with or without enlicitide decanoate.
Key Dates
- Start date
- Nov 8, 2023
- Status verified
- Nov 2024
- Primary completion
- Dec 29, 2023
- Completion
- Dec 29, 2023
Study Design
- Enrollment
- 18 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: AtorvastatinParticipants receive a single oral dose of atorvastatin (Treatment A) on Day 1.
- Experimental: Enlicitide Decanoate + AtorvastatinParticipants receive a single oral dose of enlicitide decanoate plus a single oral dose of atorvastatin (Treatment B) on Day 1.
- Experimental: Enlicitide DecanoateParticipants receive a single oral dose of enlicitide decanoate (Treatment C) on Day 1.
Primary Outcome Measure
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Atorvastatin and its Metabolites [ Time Frame: At designated timepoints (up to approximately 8 days) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Celerion (Site 0001) | Lincoln | Nebraska | 68502 | - |
Find similar trials in Lincoln, NE
By research site
Related Studies
- A Study to Evaluate Safety, Tolerability, and Immunogenicity of V350A and V350B in Healthy Participants (V350-001).PHASE1 · Recruiting · Merck Sharp & Dohme LLC · Glendale, California
- BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their BabiesPHASE3 · Recruiting · Pfizer · Birmingham, Alabama
- A Phase 1 Study of BLKR201 in Healthy Adult ParticipantsPHASE1 · Recruiting · Formation Bio, Inc. · Lincoln, Nebraska
- Study of New Magnetic Resonance Imaging Methods of the BrainRecruiting · National Institute of Neurological Disorders and Stroke (NINDS) · Bethesda, Maryland