HealthyPhase 1NCT06699355
A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Atorvastatin in Healthy Adult Participants (MK-0616-024)
A Phase 1 study testing Enlicitide Decanoate and Atorvastatin in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Enlicitide Decanoate and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2023to 29 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- History of gastrointestinal disease which may affect food and drug absorption or has had a gastric bypass or similar surgery
- History of cancer (malignancy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Effect of MK-0616 and Atorvastatin on Their Respective Pharmacokinetics in Healthy Adult Participants
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.
- Conditions
- Healthy
- Being tested
- Enlicitide Decanoate, Atorvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enlicitide DecanoateDrug
Oral administration
AtorvastatinDrug
Also called Lipitor
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | Participants receive a single oral dose of atorvastatin (Treatment A) on Day 1. Receives: Drug: Atorvastatin |
| Enlicitide Decanoate + Atorvastatin | Experimental | Participants receive a single oral dose of enlicitide decanoate plus a single oral dose of atorvastatin (Treatment B) on Day 1. Receives: Drug: Enlicitide Decanoate; Drug: Atorvastatin |
| Enlicitide Decanoate | Experimental | Participants receive a single oral dose of enlicitide decanoate (Treatment C) on Day 1. Receives: Drug: Enlicitide Decanoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Atorvastatin and its Metabolites
Blood samples will be collected to determine the AUC0-Inf of atorvastatin and its metabolites.
Measured: At designated timepoints (up to approximately 8 days)
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Atorvastatin and its Metabolites
Blood samples will be collected to determine the AUC0-Last of atorvastatin and its metabolites.
Measured: At designated timepoints (up to approximately 8 days)
Maximum Plasma Concentration (Cmax) of Atorvastatin and its Metabolites
Blood samples will be collected to determine the Cmax of atorvastatin and its metabolites.
Measured: At designated timepoints (up to approximately 8 days)
Time to Maximum Plasma Concentration (Tmax) of Atorvastatin and its Metabolites
Blood samples will be collected to determine the Tmax of atorvastatin and its metabolites.
Measured: At designated timepoints (up to approximately 8 days)
Apparent Terminal Half-Life (t1/2) of Atorvastatin and its Metabolites
Blood samples will be collected to determine the t1/2 of atorvastatin and its metabolites.
Measured: At designated timepoints (up to approximately 8 days)
Apparent Clearance (CL/F) of Atorvastatin
Blood samples will be collected to determine the CL/F of atorvastatin.
Measured: At designated timepoints (up to approximately 8 days)
Apparent Volume of Distribution (Vz/F) of Atorvastatin
Blood samples will be collected to determine the Vz/F of atorvastatin.
Measured: At designated timepoints (up to approximately 8 days)
Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24hrs) of Enlicitide Decanoate
Blood samples will be collected to determine the AUC0-24hrs of enlicitide decanoate.
Measured: At designated timepoints (up to approximately 24 hours)
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate
Blood samples will be collected to determine the AUC0-Inf of enlicitide decanoate.
Measured: At designated timepoints (up to approximately 8 days)
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Decanoate
Blood samples will be collected to determine the AUC0-Last of enlicitide decanoate.
Measured: At designated timepoints (up to approximately 8 days)
Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate
Blood samples will be collected to determine the Cmax of enlicitide decanoate.
Measured: At designated timepoints (up to approximately 8 days)
Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate
Blood samples will be collected to determine the Tmax of enlicitide decanoate.
Measured: At designated timepoints (up to approximately 8 days)
Apparent Terminal Half-Life (t1/2) of Enlicitide Decanoate
Blood samples will be collected to determine the t1/2 of enlicitide decanoate.
Measured: At designated timepoints (up to approximately 8 days)
Apparent Clearance (CL/F) of Enlicitide Decanoate
Blood samples will be collected to determine the CL/F of enlicitide decanoate.
Measured: At designated timepoints (up to approximately 8 days)
Apparent Volume of Distribution (Vz/F) of Enlicitide Decanoate
Blood samples will be collected to determine the Vz/F of enlicitide decanoate.
Measured: At designated timepoints (up to approximately 8 days)
Secondary outcomes (2)
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Measured: Up to approximately 10 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Measured: Up to approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start8 Nov 2023
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699355
- Sponsor's protocol ID
- 0616-024
- Other IDs
- MK-0616-024
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Effect of MK-0616 and Atorvastatin on Their Respective Pharmacokinetics in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06699355
- Acronym / sponsor ID
- 0616-024
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: AtorvastatinParticipants receive a single oral dose of atorvastatin (Treatment A) on Day 1. |
| Enlicitide Decanoate + Atorvastatin | Experimental | Drug: Enlicitide Decanoate, Drug: AtorvastatinParticipants receive a single oral dose of enlicitide decanoate plus a single oral dose of atorvastatin (Treatment B) on Day 1. |
| Enlicitide Decanoate | Experimental | Drug: Enlicitide DecanoateParticipants receive a single oral dose of enlicitide decanoate (Treatment C) on Day 1. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- History of gastrointestinal disease which may affect food and drug absorption or has had a gastric bypass or similar surgery
- History of cancer (malignancy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enlicitide DecanoateOral administration | Drug | Enlicitide Decanoate, Enlicitide Decanoate + Atorvastatin |
| AtorvastatinAlso: LipitorOral administration | Drug | Atorvastatin, Enlicitide Decanoate + Atorvastatin |
Primary outcome
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Atorvastatin and its Metabolites
Time frame: At designated timepoints (up to approximately 8 days)
Blood samples will be collected to determine the AUC0-Inf of atorvastatin and its metabolites.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Atorvastatin and its Metabolites
Time frame: At designated timepoints (up to approximately 8 days)
Blood samples will be collected to determine the AUC0-Last of atorvastatin and its metabolites.
Maximum Plasma Concentration (Cmax) of Atorvastatin and its Metabolites
Time frame: At designated timepoints (up to approximately 8 days)
Blood samples will be collected to determine the Cmax of atorvastatin and its metabolites.
Time to Maximum Plasma Concentration (Tmax) of Atorvastatin and its Metabolites
Time frame: At designated timepoints (up to approximately 8 days)
Blood samples will be collected to determine the Tmax of atorvastatin and its metabolites.
Apparent Terminal Half-Life (t1/2) of Atorvastatin and its Metabolites
Time frame: At designated timepoints (up to approximately 8 days)
Blood samples will be collected to determine the t1/2 of atorvastatin and its metabolites.
Apparent Clearance (CL/F) of Atorvastatin
Time frame: At designated timepoints (up to approximately 8 days)
Blood samples will be collected to determine the CL/F of atorvastatin.
Apparent Volume of Distribution (Vz/F) of Atorvastatin
Time frame: At designated timepoints (up to approximately 8 days)
Blood samples will be collected to determine the Vz/F of atorvastatin.
Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24hrs) of Enlicitide Decanoate
Time frame: At designated timepoints (up to approximately 24 hours)
Blood samples will be collected to determine the AUC0-24hrs of enlicitide decanoate.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate
Time frame: At designated timepoints (up to approximately 8 days)
Blood samples will be collected to determine the AUC0-Inf of enlicitide decanoate.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Decanoate
Time frame: At designated timepoints (up to approximately 8 days)
Blood samples will be collected to determine the AUC0-Last of enlicitide decanoate.
Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate
Time frame: At designated timepoints (up to approximately 8 days)
Blood samples will be collected to determine the Cmax of enlicitide decanoate.
Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate
Time frame: At designated timepoints (up to approximately 8 days)
Blood samples will be collected to determine the Tmax of enlicitide decanoate.
Apparent Terminal Half-Life (t1/2) of Enlicitide Decanoate
Time frame: At designated timepoints (up to approximately 8 days)
Blood samples will be collected to determine the t1/2 of enlicitide decanoate.
Apparent Clearance (CL/F) of Enlicitide Decanoate
Time frame: At designated timepoints (up to approximately 8 days)
Blood samples will be collected to determine the CL/F of enlicitide decanoate.
Apparent Volume of Distribution (Vz/F) of Enlicitide Decanoate
Time frame: At designated timepoints (up to approximately 8 days)
Blood samples will be collected to determine the Vz/F of enlicitide decanoate.
2 secondary outcomes
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 10 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Enlicitide Decanoate and Atorvastatin in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Atorvastatin and its Metabolites (time frame: At designated timepoints (up to approximately 8 days)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.