NCT07300280 - A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039) | Crick | Crick

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

Phase 1Active Not RecruitingNCT07300280

Merck Sharp & Dohme LLC60 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

60

Conditions

Interventions

Enlicitide/rosuvastatin fixed dose combination (FDC) or enlicitide/rosuvastatin FDC formulation B oral tablets

Oral tablet

RosuvastatinDRUG

Oral tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Celerion ( Site 0001)

Tempe, Arizona, United States

Outcomes

Primary Outcomes

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide

Blood samples will be collected to determine the AUC0-inf of enlicitide in plasma

Time frame: Pre dose and at designated time points up to 168 hours post dose

AUC0-Inf of Rosuvastatin

Blood samples will be collected to determine the AUC0-inf of rosuvastatin in plasma

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

Blood samples will be collected to determine the AUC0-last of enlicitide in plasma

Time frame: Pre dose and at designated time points up to 168 hours post dose

AUC0-Last of Rosuvastatin

Blood samples will be collected to determine the AUC0-last of rosuvastatin in plasma

Time frame: Pre dose and at designated time points up to 168 hours post dose

Maximum Plasma Concentration (Cmax) of Enlicitide

Blood samples will be collected to determine the cmax of enlicitide in plasma

Time frame: Pre dose and at designated time points up to 168 hours post dose

Cmax of Rosuvastatin

Blood samples will be collected to determine the cmax of rosuvastatin in plasma

Time frame: Pre dose and at designated time points up to 168 hours post dose

Secondary Outcomes

Number of Participants who Experience an Adverse Event (AE)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.