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Completed

NCT Number: NCT06662396

A Study of Diltiazem With a Single Dose of MK-6552 in Healthy Adult Participants (MK-6552-007)

The main goal of this study is to learn what happens to MK-6552 in a person's body over time (a pharmacokinetic or PK study). Researchers want to know what happens to MK-6552 in healthy adults when a single dose of MK-6552 is given with multiple doses of diltiazem. The researchers believe that multiple doses of diltiazem will not affect the highest amount of MK-6552 in the blood.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON (Site 0001)

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

  • Is in good health before randomization
  • Body Mass Index (BMI) between 18 and 32 kg/m^2, inclusive

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

  • History of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
  • History of cancer (malignancy)

Treatment and study plan

MK-6552

Drug

Oral Gelatin Coated Capsule

Diltiazem

Drug

Oral Extended-Release Capsule

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of MK-6552

    Time frame: Pre-dose and at designated time points up to 24 hours post dose

    Blood samples will be collected to determine the Cmax of MK-6552 in plasma.

Secondary outcomes

  1. Number of Participants Who Experience and Adverse Event (AEs)

    Time frame: Up to approximately 20 days

    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.

  2. Number of Participants Who Discontinue Study Due to an AE

    Time frame: Up to approximately 20 days

    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.

  3. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552

    Time frame: Pre-dose and at designated time points up to 96 hours post dose

    Blood samples will be collected to determine the AUC0-inf of MK-6552 in plasma.

  4. Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of MK-6552

    Time frame: Pre-dose and at designated time points up to 24 hours post dose

    Blood samples will be collected to determine the AUC0-24 of MK-6552 in plasma.

  5. Time to Maximum Plasma Concentration (Tmax) of MK-6552

    Time frame: Pre-dose and at designated time points up to 96 hours post dose

    Blood samples will be collected to determine the Tmax of MK-6552 in plasma.

  6. Concentration of MK-6552 at 6 Hours Postdose (C6h)

    Time frame: Pre-dose and at designated time points up to 6 hours post dose

    Blood samples will be collected to determine the C6h of MK-6552 in plasma.

  7. Concentration of MK-6552 at 8 Hours Postdose (C8h)

    Time frame: Pre-dose and at designated time points up to 8 hours post dose

    Blood samples will be collected to determine the C8h of MK-6552 in plasma.

  8. Apparent Clearance (CL/F) of MK-6552

    Time frame: Pre-dose and at designated time points up to 96 hours post dose

    Blood samples will be collected to determine the CL/F of MK-6552 in plasma.

  9. Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-6552

    Time frame: Pre-dose and at designated time points up to 96 hours post dose

    Blood samples will be collected to determine the Vz/F of MK-6552 in plasma.

  10. Apparent Terminal Half-Life (t1/2) of MK-6552

    Time frame: Pre-dose and at designated time points up to 96 hours post dose

    Blood samples will be collected to determine the t1/2 of MK-6552 in plasma.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Study to Evaluate the Effects of Coadministration of Diltiazem on the Plasma Pharmacokinetics of a Single Dose of MK-6552 in Healthy Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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