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Recruiting NCT07300280

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

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MK-0616A, Enlicitide, Rosuvastatin.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Clinical Study to Evaluate the Relative Bioavailability of FDC Tablets Containing Enlicitide and Rosuvastatin, Compared to Enlicitide and Rosuvastatin Administered Concomitantly as Single Entities, in Healthy Adult Participants

Overview

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.

Interventions

  • Drug MK-0616A
    Enlicitide/rosuvastatin fixed dose combination (FDC) or enlicitide/rosuvastatin FDC formulation B oral tablets
  • Drug Enlicitide
    Oral tablet
  • Drug Rosuvastatin
    Oral tablet

Primary outcome measures

  • Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide [Time frame: Pre dose and at designated time points up to 168 hours post dose]
  • AUC0-Inf of Rosuvastatin [Time frame: Pre dose and at designated time points up to 168 hours post dose]
  • Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitde [Time frame: Pre dose and at designated time points up to 168 hours post dose]
  • AUC0-Last of Rosuvastatin [Time frame: Pre dose and at designated time points up to 168 hours post dose]
  • Maximum Plasma Concentration (Cmax) of Enlicitide [Time frame: Pre dose and at designated time points up to 168 hours post dose]
  • Cmax of Rosuvastatin [Time frame: Pre dose and at designated time points up to 168 hours post dose]
Secondary outcome measures (2)
  • Number of Participants who Experience an Adverse Event (AE) [Time frame: Up to approximately 9 weeks]
  • Number of Participants Who Discontinue Study Treatment Due to an AE [Time frame: Up to approximately 8 days after first dose]

Eligibility criteria

The main 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Celerion ( Site 0001) — Tempe

Identifiers

NCT: NCT07300280 · 0616A-039

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗