A Clinical Study To Understand How Radiolabeled MK-5475 Is Taken Up By The Body, Broken Down And Then Removed From The Body in Healthy Participants (MK-5475-011)

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

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2022-10-25

Brief Summary

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The goal of this study is to understand how radiolabeled MK-5475 administered intravenously (IV) is taken up by the body, broken down and then removed from the body in healthy male participants. The study also aims to understand how much of the compound is broken down and how much leaves the body unchanged.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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[14C] MK-5475

\[14C\] MK-5475 is administered as single IV bolus dose of 100μg on Day 1.

Group Type EXPERIMENTAL

[14C] MK-5475

Intervention Type DRUG

\[14C\] MK-5475 is administered as a single IV bolus dose in healthy male participants on Day 1.

Interventions

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[14C] MK-5475

\[14C\] MK-5475 is administered as a single IV bolus dose in healthy male participants on Day 1.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Is in good health.
* Body mass index (BMI) \>18 and ≤32 kg/m2, inclusive.

Exclusion Criteria

* Has history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
* Has significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food.
* Has had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) or blood products within 4 weeks prior to the prestudy (screening).
* Has history of exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
* Has participated in more than 3 radiolabeled drug studies in the last 12 months.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes