A Study of Levothyroxine and Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-028)
Part of paid clinical trials in Lincoln, Nebraska.
- Sponsor
- Merck Sharp & Dohme LLC
- Study ID
- NCT06625814
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - 50 Years
- Healthy Volunteers
- Accepted
Interventions
- Levothyroxine — DRUGsingle oral dose
- Enlicitide Decanoate — DRUGsingle oral dose
Study Details
Levothyroxine (T4) is a man-made thyroid hormone used to treat certain thyroid conditions. After taking levothyroxine, a person's body changes it to triiodothyronine (T3). The amount of levothyroxine in a person's blood must be carefully controlled to maintain proper function. Enlicitide decanoate was designed to lower the amount of cholesterol in a person's blood. Researchers want to learn about levothyroxine when taken at the same time with enlicitide decanoate. They want to: * Measure a person's blood to find out if the amount of levothyroxine in the blood is the same when levothyroxine is taken alone or with enlicitide decanoate * Learn about the safety of levothyroxine when taken alone or with enlicitide decanoate and if people tolerate it
Key Dates
- Start date
- Jul 8, 2024
- Status verified
- Sep 2024
- Primary completion
- Aug 19, 2024
- Completion
- Sep 11, 2024
Study Design
- Enrollment
- 28 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: LevothyroxineParticipants will receive a single oral dose of levothyroxine.
- Experimental: Levothyroxine Plus Enlicitide DecanoateParticipants will receive a single oral dose of levothyroxine and a single oral dose of enlicitide decanoate at the same time.
Primary Outcome Measure
Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Levothyroxine (total T4) [ Time Frame: At designated timepoints (up to approximately 48 hours postdose) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Celerion (Site 0001) | Lincoln | Nebraska | 68502 | - |
Find similar trials in Lincoln, NE
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