A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039)

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

  • Healthy

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