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

NCT ID: NCT06649877

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-20

Study Completion Date

2023-07-13

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Abdomen Injection

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

Group Type EXPERIMENTAL

MK-6194

Intervention Type BIOLOGICAL

single injected dose

Thigh Injection

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

Group Type EXPERIMENTAL

MK-6194

Intervention Type BIOLOGICAL

single injected dose

Interventions

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MK-6194

single injected dose

Intervention Type BIOLOGICAL

Other Intervention Names

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PT101

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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

South Miami, Florida, United States

Site Status

Countries

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United States

Related Links

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https://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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MK-6194-013

Identifier Type: OTHER

Identifier Source: secondary_id

6194-013

Identifier Type: -

Identifier Source: org_study_id

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