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

NCT06592339 | Completed Phase 1 FDA Drug

• 2 other identifiers: 0616-009MK-0616-009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  Predose and at designated timepoints up to 168 hours postdose

Secondary Outcomes (2)

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 2 months

• Number of Participants Who Discontinue Study Due to an AE

  Up to approximately 2 months

Study Arms (6)

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.

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.

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.

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.

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.

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.

Drug: MK-0616

Interventions

MK-0616 DRUG

oral administration

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

QPS-MRA, LLC-Early Phase

South Miami, Florida, 33143, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

MK-0616

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: October 25, 2022
• Primary Completion: December 29, 2022
• Study Completion: December 29, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)