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

NCT06649877 | Completed Phase 1 FDA Drug

• 2 other identifiers: 6194-013MK-6194-013
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Number of Participants Who Experience an Adverse Event

  Up to approximately 12 weeks

• Number of Participants Who Discontinue Study Due to an AE

  Up to approximately 12 weeks

Study Arms (2)

Abdomen Injection

EXPERIMENTAL

Participants will receive a single dose of MK-6194 injected into the abdomen.

Biological: MK-6194

Thigh Injection

EXPERIMENTAL

Participants will receive a single dose of MK-6194 injected into the thigh.

Biological: MK-6194

Interventions

MK-6194 BIOLOGICAL

single injected dose

Also known as: PT101

Abdomen Injection; Thigh Injection

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

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

South Miami, Florida, 33143, United States

Location

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 21, 2024
• Study Start: March 20, 2023
• Primary Completion: July 13, 2023
• Study Completion: July 13, 2023
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)