Print

Purpose

This goal of this trial is to learn about two medicines, enlicitide and rosuvastatin, in healthy people. Researchers will compare the amounts of enlicitide and rosuvastatin in a person's body over time, when they are given as separate medicines and when they are combined into one tablet.

Condition

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

include but are not limited to the following: - Is medically healthy with no clinically significant medical history - Is a non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to study entry

Exclusion Criteria

  • Is unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to study entry - Is a female participant of childbearing potential

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Enlicitide + Rosuvastatin Part 1 		Participants in Part 1 will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet
  • Drug: Enlicitide
    Oral tablet
    Other names:
    • MK-0616
  • Drug: Rosuvastatin
    Oral tablet
Experimental
MK-0616A Part 1 		Participants in Part 1 will receive a single dose of MK-0616A
  • Drug: MK-0616A
    Enlicitide/rosuvastatin fixed dose combination (FDC) or enlicitide/rosuvastatin FDC formulation B oral tablets
    Other names:
    • enlicitide/rosuvastatin calcium
Experimental
Enlicitide + Rosuvastatin Part 2 		Participants in Part 2 will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet
  • Drug: Enlicitide
    Oral tablet
    Other names:
    • MK-0616
  • Drug: Rosuvastatin
    Oral tablet
Experimental
MK-0616A Part 2 		Participants in Part 2 will receive a single dose of MK-0616A formulation B
  • Drug: MK-0616A
    Enlicitide/rosuvastatin fixed dose combination (FDC) or enlicitide/rosuvastatin FDC formulation B oral tablets
    Other names:
    • enlicitide/rosuvastatin calcium

Recruiting Locations

Celerion ( Site 0001)
Tempe, Arizona 85283
Contact:
Study Coordinator
888-577-8839

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.