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Enpatoran Human Mass Balance and Absolute Bioavailability Study

NCT05110027 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-04-04

No results posted yet for this study

Summary

The purpose of Period 1 of this study is to provide a definitive quantitative characterization of the mass balance, and rates and routes of excretion of enpatoran, and to determine and quantify enpatoran and its metabolites in excreta (urine and feces) and plasma. The purpose of Period 2 of this study is to determine the absolute oral bioavailability of enpatoran. Total minimum duration of study participation for each participant is approximately 50 days.

Conditions

  • Healthy

Interventions

DRUG

Enpatoran

Participants will receive single oral dose of enpatoran tablet on Day 1

DRUG

[14C]enpatoran microtracer

Participants will receive single oral dose of non-labeled enpatoran solution spiked with microtracer of \[14C\]enpatoran on Day 1 of Period 1.

DRUG

[14C]enpatoran microdose

Participants will receive intravenous \[14C\]enpatoran microdose administered at 1.5 hours after the oral dose of enpatoran on Day 1 of Period 2.

Sponsors & Collaborators

  • Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-05
Primary Completion
2021-12-24
Completion
2021-12-24

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05110027 on ClinicalTrials.gov