A Clinical Trial of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-044)

Purpose

The goal of this trial is to learn what happens to different formulations (types) of enlicitide in a healthy person's body over time. Researchers will compare the amount of enlicitide in a healthy person's body over time when different formulations are given on an empty stomach and after a high-fat meal.

Condition

  • Healthy

Eligibility

Eligible Ages
Between 19 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Is in good health - Has a body-mass index (BMI) between ≥18.0 and ≤32.0 kg/m^2

Exclusion Criteria

  • Has history of gastrointestinal (GI) disease which might affect food and drug absorption or has had gastric bypass or similar surgery. Examples of GI disease include (but are not limited to) recurrent vomiting, inflammatory bowel disease, chronic intestinal disease accompanied by a disturbance in digestion and absorption, Roemheld's syndrome, and severe hernia - Has a history of cancer (malignancy) - Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) - Is lactose intolerant

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
Treatment A: Enlicitide Reference 		Participants will receive a single oral dose of enlicitide reference formulation.
  • Drug: Enlicitide
    Oral Tablet
    Other names:
    • MK-0616
    • enlicitide decanoate
Experimental
Treatment B: Enlicitide Formulation Test 1 - Fed 		Participants will receive a single oral dose of enlicitide formulation test 1 after a high-fat breakfast.
  • Drug: Enlicitide
    Oral Tablet
    Other names:
    • MK-0616
    • enlicitide decanoate
Experimental
Treatment C: Enlicitide Formulation Test 1 - Fasted 		Participants will receive a single oral dose of enlicitide formulation test 1 under fasted conditions.
  • Drug: Enlicitide
    Oral Tablet
    Other names:
    • MK-0616
    • enlicitide decanoate
Experimental
Treatment D: Enlicitide Formulation Test 2 - Fed 		Participants will receive a single oral dose of enlicitide formulation test 2 after a high-fat breakfast.
  • Drug: Enlicitide
    Oral Tablet
    Other names:
    • MK-0616
    • enlicitide decanoate
Experimental
Treatment E: Enlicitide Formulation Test 2 - Fasted 		Participant will receive a single oral dose of enlicitide formulation test 2 under fasted conditions.
  • Drug: Enlicitide
    Oral Tablet
    Other names:
    • MK-0616
    • enlicitide decanoate

Recruiting Locations

Celerion ( Site 0001)
Lincoln, Nebraska 68502
Contact:
Study Coordinator
402-476-2811

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

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