NCT05110027

Enpatoran Human Mass Balance and Absolute Bioavailability Study

Phase I, Open-Label, 2-Period, Single-Sequence Study to Evaluate the Mass Balance and Absorption, Disposition, Metabolism and Excretion of [14C]Enpatoran, and the Absolute Bioavailability of Enpatoran in Healthy Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-11-05
• Primary completion: 2021-12-24
• Completion: 2021-12-24
• First posted: 2021-11-05
• Last updated: 2022-04-04

Locations

1 site across 1 country: Netherlands