MK-6194 Site of Injection Study in Healthy Adult Participants (MK-6194-013)

A Randomized Clinical Study to Evaluate the Impact of Injection Site (Thigh vs Abdomen) on the Pharmacokinetics and Relative Bioavailability of Subcutaneously Injected MK-6194 in Healthy Adult Participants

The goal of this study is to learn what happens to MK-6194 in a healthy person's body when different injection sites are used. Researchers will compare what happens to MK-6194 in a healthy person's body when it is injected into the abdomen and when it is injected into the thigh. Researchers think that the average amount of MK-6194 in a person's body over time will be similar when injected into the thigh or abdomen. They also want to learn if it is safe to inject MK-6194 into the abdomen and thigh, and if people tolerate it.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: MK-6194

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

• Is in good health
• Has a body mass index (BMI) within 18 to 35 kg/m2 and weighs at least 50 kg

Exclusion Criteria:

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

• Has a 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
• Has a history of cancer

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abdomen Injection; Participants will receive a single dose of MK-6194 injected into the abdomen.	Biological: MK-6194; single injected dose; Other Names: PT101
Experimental: Thigh Injection; Participants will receive a single dose of MK-6194 injected into the thigh.	Biological: MK-6194; single injected dose; Other Names: PT101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-6194	Blood samples will be collected to determine the AUC0-Last of MK-6194.	At designated timepoints (up to approximately 4 weeks postdose)
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6194	Blood samples will be collected to determine the AUC0-Inf of MK-6194.	At designated timepoints (up to approximately 4 weeks postdose)
Maximum Plasma Concentration (Cmax) of MK-6194	Blood samples will be collected to determine the Cmax of MK-6194.	At designated timepoints (up to approximately 4 weeks postdose)
Time to Maximum Plasma Concentration (Tmax) of MK-6194	Blood samples will be collected to determine the Tmax of MK-6194.	At designated timepoints (up to approximately 4 weeks postdose)
Apparent Clearance (CL/F) of MK-6194	Blood samples will be collected to determine the CL/F of MK-6194.	At designated timepoints (up to approximately 4 weeks postdose)
Apparent Terminal Half-life (t1/2) of MK-6194	Blood samples will be collected to determine the t1/2 of MK-6194.	At designated timepoints (up to approximately 4 weeks postdose)
Apparent Volume of Distribution (Vz/F) of MK-6194	Blood samples will be collected to determine the Vz/F of MK-6194.	At designated timepoints (up to approximately 4 weeks postdose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experience an Adverse Event	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.	Up to approximately 12 weeks
Number of Participants Who Discontinue Study Due to an AE	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported.	Up to approximately 12 weeks

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Actual): July 13, 2023
• Study Completion (Actual): July 13, 2023

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 6194-013; MK-6194-013 (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