Clinical trial NCT06699355: A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Atorvastatin in Healthy Adult Participants (MK-0616-024)
Official title: A Clinical Study to Evaluate the Effect of MK-0616 and Atorvastatin on Their Respective Pharmacokinetics in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-11-21
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this study is to learn what happens to enlicitide decanoate and atorvastatin in a healthy person's body over time. Researchers want to learn what happens to enlicitide decanoate in the body when it is given with and without another medicine called atorvastatin and what happens to atorvastatin in the body when it is given with or without enlicitide decanoate.


Eligibility criteria: Inclusion Criteria:

* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, standard and orthostatic vital signs, and electrocardiograms (ECGs)

Exclusion Criteria:

* History of gastrointestinal disease which may affect food and drug absorption or has had a gastric bypass or similar surgery
* History of cancer (malignancy)

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Atorvastatin and its Metabolites
timeFrame: At designated timepoints (up to approximately 8 days)
measure: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Atorvastatin and its Metabolites
timeFrame: At designated timepoints (up to approximately 8 days)
measure: Maximum Plasma Concentration (Cmax) of Atorvastatin and its Metabolites
timeFrame: At designated timepoints (up to approximately 8 days)
measure: Time to Maximum Plasma Concentration (Tmax) of Atorvastatin and its Metabolites
timeFrame: At designated timepoints (up to approximately 8 days)
measure: Apparent Terminal Half-Life (t1/2) of Atorvastatin and its Metabolites
timeFrame: At designated timepoints (up to approximately 8 days)
measure: Apparent Clearance (CL/F) of Atorvastatin
timeFrame: At designated timepoints (up to approximately 8 days)
measure: Apparent Volume of Distribution (Vz/F) of Atorvastatin
timeFrame: At designated timepoints (up to approximately 8 days)
measure: Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24hrs) of Enlicitide Decanoate
timeFrame: At designated timepoints (up to approximately 24 hours)
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate
timeFrame: At designated timepoints (up to approximately 8 days)
measure: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Decanoate
timeFrame: At designated timepoints (up to approximately 8 days)
measure: Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate
timeFrame: At designated timepoints (up to approximately 8 days)
measure: Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate
timeFrame: At designated timepoints (up to approximately 8 days)
measure: Apparent Terminal Half-Life (t1/2) of Enlicitide Decanoate
timeFrame: At designated timepoints (up to approximately 8 days)
measure: Apparent Clearance (CL/F) of Enlicitide Decanoate
timeFrame: At designated timepoints (up to approximately 8 days)
measure: Apparent Volume of Distribution (Vz/F) of Enlicitide Decanoate
timeFrame: At designated timepoints (up to approximately 8 days)
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 10 weeks
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 6 weeks
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion (Site 0001)
state: Nebraska
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: