HealthyPhase 1NCT06625814
A Study of Levothyroxine and Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-028)
A Phase 1 study testing Levothyroxine and Enlicitide Decanoate in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
Levothyroxine (T4) is a man-made thyroid hormone used to treat certain thyroid conditions. After taking levothyroxine, a person's body changes it to triiodothyronine (T3). The amount of levothyroxine in a person's blood must be carefully controlled to maintain proper function. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Levothyroxine and Enlicitide Decanoate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2024to 11 Sep 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The key inclusion criteria include but are not limited to the following:
- Medically healthy with no clinically significant medical history
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing
Who cannot join
- The key exclusion criteria include but are not limited to the following:
- History of cardiovascular disease or diabetes mellitus
- History of cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Effect of MK-0616 on the Pharmacokinetics of Levothyroxine in Healthy Adult Participants
Levothyroxine (T4) is a man-made thyroid hormone used to treat certain thyroid conditions. After taking levothyroxine, a person's body changes it to triiodothyronine (T3). The amount of levothyroxine in a person's blood must be carefully controlled to maintain proper function. Enlicitide decanoate was designed to lower the amount of cholesterol in a person's blood.
Researchers want to learn about levothyroxine when taken at the same time with enlicitide decanoate. They want to:
- Measure a person's blood to find out if the amount of levothyroxine in the blood is the same when levothyroxine is taken alone or with enlicitide decanoate
- Learn about the safety of levothyroxine when taken alone or with enlicitide decanoate and if people tolerate it
- Conditions
- Healthy
- Being tested
- Levothyroxine, Enlicitide Decanoate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevothyroxineDrug
Also called Synthroid
single oral dose
Enlicitide DecanoateDrug
Also called MK-0616
single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Levothyroxine | Experimental | Participants will receive a single oral dose of levothyroxine. Receives: Drug: Levothyroxine |
| Levothyroxine Plus Enlicitide Decanoate | Experimental | Participants will receive a single oral dose of levothyroxine and a single oral dose of enlicitide decanoate at the same time. Receives: Drug: Levothyroxine; 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 48 hours (AUC0-48hrs) of Levothyroxine (total T4)
Blood samples will be collected to determine the AUC0-48hr of Levothyroxine (T4).
Measured: At designated timepoints (up to approximately 48 hours postdose)
Maximum Plasma Concentration (Cmax) of Levothyroxine (total T4)
Blood samples will be collected to determine the Cmax of Levothyroxine (T4).
Measured: At designated timepoints (up to approximately 48 hours postdose)
Time to Maximum Plasma Concentration (Tmax) of Levothyroxine (total T4)
Blood samples will be collected to determine the Tmax of Levothyroxine (T4).
Measured: At designated timepoints (up to approximately 48 hours postdose)
Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Triiodothyronine (total T3)
Blood samples will be collected to determine the AUC0-48hr of triiodothyronine (T3).
Measured: At designated timepoints (up to approximately 48 hours postdose)
Maximum Plasma Concentration (Cmax) of Triiodothyronine (total T3)
Blood samples will be collected to determine the Cmax of triiodothyronine (T3).
Measured: At designated timepoints (up to approximately 48 hours postdose)
Time to Maximum Plasma Concentration (Tmax) of Triiodothyronine (total T3)
Blood samples will be collected to determine the Tmax of triiodothyronine (T3).
Measured: At designated timepoints (up to approximately 48 hours postdose)
Secondary outcomes (2)
Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE)
An adverse event (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. An AE will be considered treatment-emergent if the onset date and time is at the time of or after the first study drug administration. The number of participants who experience a TEAE will be reported.
Measured: Up to approximately 7 weeks
Number of Participants Who Discontinue Study Due to a TEAE
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. An AE will be considered treatment-emergent if the onset date and time is at the time of or after the first study drug administration. The number of participants who discontinue study due to a TEAE will be reported.
Measured: Up to approximately 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start8 Jul 2024
- Primary completion19 Aug 2024
- Study completion11 Sep 2024
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625814
- Sponsor's protocol ID
- 0616-028
- Other IDs
- MK-0616-028
- Status last verified
- Sep 2024
- First submitted
- 1 Oct 2024
- Last updated
- 3 Oct 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 3 Oct 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 on the Pharmacokinetics of Levothyroxine in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06625814
- Acronym / sponsor ID
- 0616-028
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 19 Aug 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 3 Oct 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.
Levothyroxine (T4) is a man-made thyroid hormone used to treat certain thyroid conditions. After taking levothyroxine, a person's body changes it to triiodothyronine (T3). The amount of levothyroxine in a person's blood must be carefully controlled to maintain proper function. Enlicitide decanoate was designed to lower the amount of cholesterol in a person's blood.
Researchers want to learn about levothyroxine when taken at the same time with enlicitide decanoate. They want to:
- Measure a person's blood to find out if the amount of levothyroxine in the blood is the same when levothyroxine is taken alone or with enlicitide decanoate
- Learn about the safety of levothyroxine when taken alone or with enlicitide decanoate and if people tolerate it
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levothyroxine | Experimental | Drug: LevothyroxineParticipants will receive a single oral dose of levothyroxine. |
| Levothyroxine Plus Enlicitide Decanoate | Experimental | Drug: Levothyroxine, Drug: Enlicitide DecanoateParticipants will receive a single oral dose of levothyroxine and a single oral dose of enlicitide decanoate at the same time. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Medically healthy with no clinically significant medical history
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing
Key exclusion criteria (3 listed)
- History of cardiovascular disease or diabetes mellitus
- History of cancer
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 |
|---|---|---|
| LevothyroxineAlso: Synthroidsingle oral dose | Drug | Levothyroxine, Levothyroxine Plus Enlicitide Decanoate |
| Enlicitide DecanoateAlso: MK-0616single oral dose | Drug | Levothyroxine Plus Enlicitide Decanoate |
Primary outcome
Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Levothyroxine (total T4)
Time frame: At designated timepoints (up to approximately 48 hours postdose)
Blood samples will be collected to determine the AUC0-48hr of Levothyroxine (T4).
Maximum Plasma Concentration (Cmax) of Levothyroxine (total T4)
Time frame: At designated timepoints (up to approximately 48 hours postdose)
Blood samples will be collected to determine the Cmax of Levothyroxine (T4).
Time to Maximum Plasma Concentration (Tmax) of Levothyroxine (total T4)
Time frame: At designated timepoints (up to approximately 48 hours postdose)
Blood samples will be collected to determine the Tmax of Levothyroxine (T4).
Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Triiodothyronine (total T3)
Time frame: At designated timepoints (up to approximately 48 hours postdose)
Blood samples will be collected to determine the AUC0-48hr of triiodothyronine (T3).
Maximum Plasma Concentration (Cmax) of Triiodothyronine (total T3)
Time frame: At designated timepoints (up to approximately 48 hours postdose)
Blood samples will be collected to determine the Cmax of triiodothyronine (T3).
Time to Maximum Plasma Concentration (Tmax) of Triiodothyronine (total T3)
Time frame: At designated timepoints (up to approximately 48 hours postdose)
Blood samples will be collected to determine the Tmax of triiodothyronine (T3).
2 secondary outcomes
Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to approximately 7 weeks
Number of Participants Who Discontinue Study Due to a TEAE
Time frame: Up to approximately 7 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 3 Oct 2024.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 Levothyroxine and Enlicitide Decanoate 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 3 inclusion and 3 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 3 Oct 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 48 hours (AUC0-48hrs) of Levothyroxine (total T4) (time frame: At designated timepoints (up to approximately 48 hours postdose)). The study lists 6 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 3 Oct 2024.