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Completed

NCT Number: NCT06649877

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

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

QPS-MRA, LLC-Early Phase (Site 0001)

South Miami, Florida, 33143, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

MK-6194

Biological

single injected dose

Other names: PT101

Primary outcomes

  1. Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-6194

    Time frame: At designated timepoints (up to approximately 4 weeks postdose)

    Blood samples will be collected to determine the AUC0-Last of MK-6194.

  2. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6194

    Time frame: At designated timepoints (up to approximately 4 weeks postdose)

    Blood samples will be collected to determine the AUC0-Inf of MK-6194.

  3. Maximum Plasma Concentration (Cmax) of MK-6194

    Time frame: At designated timepoints (up to approximately 4 weeks postdose)

    Blood samples will be collected to determine the Cmax of MK-6194.

  4. Time to Maximum Plasma Concentration (Tmax) of MK-6194

    Time frame: At designated timepoints (up to approximately 4 weeks postdose)

    Blood samples will be collected to determine the Tmax of MK-6194.

  5. Apparent Clearance (CL/F) of MK-6194

    Time frame: At designated timepoints (up to approximately 4 weeks postdose)

    Blood samples will be collected to determine the CL/F of MK-6194.

  6. Apparent Terminal Half-life (t1/2) of MK-6194

    Time frame: At designated timepoints (up to approximately 4 weeks postdose)

    Blood samples will be collected to determine the t1/2 of MK-6194.

  7. Apparent Volume of Distribution (Vz/F) of MK-6194

    Time frame: At designated timepoints (up to approximately 4 weeks postdose)

    Blood samples will be collected to determine the Vz/F of MK-6194.

Secondary outcomes

  1. Number of Participants Who Experience an Adverse Event

    Time frame: Up to approximately 12 weeks

    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.

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

    Time frame: Up to approximately 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 21, 2024
Registry last updated
Oct 21, 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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