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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)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: [14C] MK-5475

Study type

Interventional

Funder types

Industry

Identifiers

NCT06777602
5475-011
MK-5475-011 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

[14C] MK-5475
Experimental group
Description:
\[14C\] MK-5475 is administered as single IV bolus dose of 100μg on Day 1.
Treatment:
Drug: [14C] MK-5475

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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