HypercholesterolemiaPhase 1NCT06592339

A Study of MK-0616 in Healthy Adult Participants (MK-0616-009)

A Phase 1 study testing MK-0616 in people with Hypercholesterolemia, run by Merck Sharp & Dohme LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of the study is to learn what happens to levels of MK-0616 in the blood when MK-0616 is given in different forms. Researchers believe that there is no effect on a healthy person's body if MK-0616 is given in different forms. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Hypercholesterolemia
What is being tested?: MK-0616
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 25 Oct 2022to 29 Dec 2022
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 18 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:
Is in good health before randomization
Has a body mass index (BMI) ≥18 and ≤32 kg/m^2, inclusive

Who cannot join

The key exclusion criteria include but are not limited to the following:
Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
Has a history of cancer with pre-specified exceptions (adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study, per protocol guidelines)

Trial locations and contacts

1 site in 1 country.

United States1 site

QPS-MRA, LLC-Early Phase
South Miami, Florida, 33143

Other trials in United States

About this study

Official title: An Open-Label, Randomized, Single-Dose, 3-Period, Crossover Study to Evaluate the Comparative Bioavailability of MK-0616 Capsules and Tablet Formulations in Healthy Participants

Conditions: Hypercholesterolemia
Being tested: MK-0616
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-0616Drug
oral administration

Study groups in NCT06592339
Study group	Role	What they receive
Sequence 1: MK-0616 Reference capsule→MK-0616 Formulation 1 (F1)→MK-0616 Formulation 2 (F2)	Experimental	Period 1: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. Receives: Drug: MK-0616
Sequence 2: MK-0616 Reference capsule→MK-0616 F2→MK-0616 F1	Experimental	Period 1: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. Receives: Drug: MK-0616
Sequence 3: MK-0616 F1→MK-0616 Reference capsule→MK-0616 F2	Experimental	Period 1: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. Receives: Drug: MK-0616
Sequence 4: MK-0616 F1→MK-0616 F2→MK-0616 Reference capsule	Experimental	Period 1: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. Receives: Drug: MK-0616
Sequence 5: MK-0616 F2→MK-0616 Reference capsule →MK-0616 F1	Experimental	Period 1: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. Receives: Drug: MK-0616
Sequence 6: MK-0616 F2→MK-0616 F1→MK-0616 Reference capsule	Experimental	Period 1: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3. Receives: Drug: MK-0616

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 MK-0616
Blood samples will be collected to determine the AUC0-inf of MK-0616.
Measured: Predose and at designated timepoints up to 168 hours postdose
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hr) of MK-0616
Blood samples will be collected to determine the AUC0-24 of MK-0616.
Measured: Predose and at designated timepoints up to 24 hours postdose
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-0616
Blood samples will be collected to determine the AUC0-last of MK-0616.
Measured: Predose and at designated timepoints up to 168 hours postdose
Maximum Plasma Concentration (Cmax) of MK-0616
Blood samples will be collected to determine the Cmax of MK-0616.
Measured: Predose and at designated timepoints up to 168 hours postdose
Maximum Plasma Concentration (C24) of MK-0616
Blood samples will be collected to determine the C24 of MK-0616.
Measured: Predose and at designated timepoints up to 24 hours postdose
Apparent Terminal Half-life (t1/2) of MK-0616
Blood samples will be collected to determine the apparent t1/2 of MK-0616.
Measured: Predose and at designated timepoints up to 168 hours postdose
Time to Maximum Plasma Concentration (Tmax) of MK-0616
Blood samples will be collected at pre-specified timepoints to determine the Tmax of MK-0616.
Measured: Predose and at designated timepoints up to 168 hours postdose

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 2 months
Number of Participants Who Discontinue Study 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 discontinue study due to an AE will be reported.
Measured: Up to approximately 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Oct 202229 Dec 2022

First posted19 Sep 2024
Study start25 Oct 2022
Primary completion29 Dec 2022
Study completion29 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypercholesterolemiaStudies 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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06592339
Sponsor's protocol ID: 0616-009
Other IDs: MK-0616-009
Status last verified: Sep 2024
First submitted: 9 Sep 2024
Last updated: 19 Sep 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized, Single-Dose, 3-Period, Crossover Study to Evaluate the Comparative Bioavailability of MK-0616 Capsules and Tablet Formulations in Healthy Participants
ClinicalTrials.gov ID: NCT06592339
Acronym / sponsor ID: 0616-009
Conditions: Hypercholesterolemia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 25 Oct 2022 (actual)
Primary completion: 29 Dec 2022 (actual)
Study completion: 29 Dec 2022 (actual)
First posted: 19 Sep 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Sequence 1: MK-0616 Reference capsule→MK-0616 Formulation 1 (F1)→MK-0616 Formulation 2 (F2)	Experimental	Drug: MK-0616Period 1: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3.
Sequence 2: MK-0616 Reference capsule→MK-0616 F2→MK-0616 F1	Experimental	Drug: MK-0616Period 1: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3.
Sequence 3: MK-0616 F1→MK-0616 Reference capsule→MK-0616 F2	Experimental	Drug: MK-0616Period 1: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3.
Sequence 4: MK-0616 F1→MK-0616 F2→MK-0616 Reference capsule	Experimental	Drug: MK-0616Period 1: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3.
Sequence 5: MK-0616 F2→MK-0616 Reference capsule →MK-0616 F1	Experimental	Drug: MK-0616Period 1: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3.
Sequence 6: MK-0616 F2→MK-0616 F1→MK-0616 Reference capsule	Experimental	Drug: MK-0616Period 1: Participants receive MK-0616 F2 single dose on Day 1 orally (Period 1 = 15 days). Period 2: Participants receive MK-0616 F1 single dose on Day 1 orally (Period 2 = 15 days). Period 3: Participants receive MK-0616 reference capsule single dose on Day 1 orally (Period 3 = 15 days). A washout period of 14 days will separate Period 1, Period 2 and Period 3.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Is in good health before randomization
Has a body mass index (BMI) ≥18 and ≤32 kg/m^2, inclusive

Key exclusion criteria (3 listed)

Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
Has a history of cancer with pre-specified exceptions (adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study, per protocol guidelines)

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
MK-0616oral administration	Drug	Sequence 1: MK-0616 Reference capsule→MK-0616 Formulation 1 (F1)→MK-0616 Formulation 2 (F2), Sequence 2: MK-0616 Reference capsule→MK-0616 F2→MK-0616 F1, Sequence 3: MK-0616 F1→MK-0616 Reference capsule→MK-0616 F2, Sequence 4: MK-0616 F1→MK-0616 F2→MK-0616 Reference capsule, Sequence 5: MK-0616 F2→MK-0616 Reference capsule →MK-0616 F1, Sequence 6: MK-0616 F2→MK-0616 F1→MK-0616 Reference capsule

Primary outcome

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-0616
Time frame: Predose and at designated timepoints up to 168 hours postdose
Blood samples will be collected to determine the AUC0-inf of MK-0616.
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hr) of MK-0616
Time frame: Predose and at designated timepoints up to 24 hours postdose
Blood samples will be collected to determine the AUC0-24 of MK-0616.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-0616
Time frame: Predose and at designated timepoints up to 168 hours postdose
Blood samples will be collected to determine the AUC0-last of MK-0616.
Maximum Plasma Concentration (Cmax) of MK-0616
Time frame: Predose and at designated timepoints up to 168 hours postdose
Blood samples will be collected to determine the Cmax of MK-0616.
Maximum Plasma Concentration (C24) of MK-0616
Time frame: Predose and at designated timepoints up to 24 hours postdose
Blood samples will be collected to determine the C24 of MK-0616.
Apparent Terminal Half-life (t1/2) of MK-0616
Time frame: Predose and at designated timepoints up to 168 hours postdose
Blood samples will be collected to determine the apparent t1/2 of MK-0616.
Time to Maximum Plasma Concentration (Tmax) of MK-0616
Time frame: Predose and at designated timepoints up to 168 hours postdose
Blood samples will be collected at pre-specified timepoints to determine the Tmax of MK-0616.

2 secondary outcomes

Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 2 months
Number of Participants Who Discontinue Study Due to an AE
Time frame: Up to approximately 2 months

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 19 Sep 2024.
Merck Clinical Trials InformationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

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 MK-0616 in people with Hypercholesterolemia, 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 19 Sep 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 MK-0616 (time frame: Predose and at designated timepoints up to 168 hours postdose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06592339.

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 19 Sep 2024.