A Study of MK-6552 and the Effect of Food in Healthy Participants (MK-6552-006)

December 2, 2024 updated by: Merck Sharp & Dohme LLC

A Study to Evaluate the Pharmacokinetics of Single Dose Formulations of MK-6552 and the Effect of Food in Healthy Study Participants

The primary purpose of this study is to learn what happens to levels of MK-6552 in the blood when MK-6552 is given in different forms to healthy adult participants under fasted and fed conditions.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • South Miami, Florida, United States, 33143
        • QPS-MRA, LLC-Early Phase ( Site 0001)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

  • Be in good health

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)
  • Has received any vaccine starting from 30 days prior to study intervention or is scheduled to receive any vaccine through 30 days following study intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1: (Treatment A) → (Treatment B) → (Treatment C) → (Treatment B) → (Treatment C)
Period 1: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 2 = 4 days). Period 3: Participants receive Treatment C single dose administered orally under fasted conditions (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.
Drug: MK-6552
Oral Administration
Experimental: Sequence 2: (Treatment B) → (Treatment C) → (Treatment A) → (Treatment B) → (Treatment C)
Period 1: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions. (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.
Drug: MK-6552
Oral Administration
Experimental: Sequence 3: (Treatment C) → (Treatment A) → (Treatment B) → (Treatment B) → (Treatment C)
Period 1: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions. (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.
Drug: MK-6552
Oral Administration
Experimental: Sequence 4: (Treatment A) → (Treatment C) → (Treatment B) → (Treatment C) → (Treatment B)
Period 1: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.
Drug: MK-6552
Oral Administration
Experimental: Sequence 5: (Treatment B) → (Treatment A) → (Treatment C) → (Treatment C) → (Treatment B)
Period 1: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions. (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.
Drug: MK-6552
Oral Administration
Experimental: Sequence 6: (Treatment C) → (Treatment B) → (Treatment A) → (Treatment C) → (Treatment B)
Period 1: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions. (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.
Drug: MK-6552
Oral Administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Plasma Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-last) of MK-6552 in a Fasted State
Time Frame: Predose and at designated timepoints approximately up to 3 days postdose
Blood samples will be collected to determine the AUC0-last of MK-6552.
Predose and at designated timepoints approximately up to 3 days postdose
Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552 in a Fasted State
Time Frame: Predose and at designated timepoints approximately up to 3 days postdose
Blood samples will be collected to determine the AUC0-inf of MK-6552.
Predose and at designated timepoints approximately up to 3 days postdose
Maximum Concentration (Cmax) of MK-6552 in a Fasted State
Time Frame: Predose and at designated timepoints approximately up to 3 days postdose
Blood samples will be collected to determine the Cmax of MK-6552.
Predose and at designated timepoints approximately up to 3 days postdose
Concentration at 8 hours (C8h) of MK-6552 in a Fasted State
Time Frame: 8 hours postdose
Blood samples will be collected to determine the C8h of MK-6552.
8 hours postdose
Concentration at 16 hours (C16h) of MK-6552 in a Fasted State
Time Frame: 16 hours postdose
Blood samples will be collected to determine the C16h of MK-6552.
16 hours postdose
Time to maximum concentration (Tmax) of MK-6552 in a Fasted State
Time Frame: Predose and at designated timepoints approximately up to 3 days postdose
Blood samples will be collected to determine the Tmax of MK-6552.
Predose and at designated timepoints approximately up to 3 days postdose
Apparent Terminal Half-life (t1/2) of MK-6552 in a Fasted State
Time Frame: Predose and at designated timepoints approximately up to 3 days postdose
Blood samples will be collected to determine the t1/2 of MK-6552.
Predose and at designated timepoints approximately up to 3 days postdose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-last of MK-6552 in a Fed or Fasted State
Time Frame: Predose and at designated timepoints approximately up to 3 days postdose
Blood samples will be collected to determine the AUC0-last of MK-6552.
Predose and at designated timepoints approximately up to 3 days postdose
AUC0-inf of MK-6552 in a Fed or Fasted State
Time Frame: Predose and at designated timepoints approximately up to 3 days postdose
Blood samples will be collected to determine the AUC0-inf of MK-6552.
Predose and at designated timepoints approximately up to 3 days postdose
Cmax of MK-6552 in a Fed or Fasted State
Time Frame: Predose and at designated timepoints approximately up to 3 days postdose
Blood samples will be collected to determine the Cmax of MK-6552.
Predose and at designated timepoints approximately up to 3 days postdose
C8h of MK-6552 in a Fed or Fasted State
Time Frame: 8 hours postdose
Blood samples will be collected to determine the C8h of MK-6552.
8 hours postdose
C16h of MK-6552 in a Fed or Fasted State
Time Frame: 16 hours postdose
Blood samples will be collected to determine the C16h of MK-6552.
16 hours postdose
Tmax of MK-6552 in a Fed or Fasted State
Time Frame: Predose and at designated timepoints approximately up to 3 days postdose
Blood samples will be collected to determine the Tmax of MK-6552.
Predose and at designated timepoints approximately up to 3 days postdose
t1/2 of MK-6552 in a Fed or Fasted State
Time Frame: Predose and at designated timepoints approximately up to 3 days postdose
Blood samples will be collected to determine the t1/2 of MK-6552.
Predose and at designated timepoints approximately up to 3 days postdose
Number of participants with one or more adverse events (AE)
Time Frame: Up to approximately day 35
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who experience an AE will be reported.
Up to approximately day 35
Number of participants discontinuing from study therapy due to AE
Time Frame: Up to approximately day 35
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately day 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2024

Primary Completion (Actual)

November 15, 2024

Study Completion (Actual)

November 15, 2024

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 6552-006
  • MK-6552-006 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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