Enpatoran Human Mass Balance and Absolute Bioavailability Study

Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study ID
NCT05110027
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Enpatoran — DRUG
    Participants will receive single oral dose of enpatoran tablet on Day 1
  • [14C]enpatoran microtracer — DRUG
    Participants will receive single oral dose of non-labeled enpatoran solution spiked with microtracer of \[14C\]enpatoran on Day 1 of Period 1.
  • [14C]enpatoran microdose — DRUG
    Participants will receive intravenous \[14C\]enpatoran microdose administered at 1.5 hours after the oral dose of enpatoran on Day 1 of Period 2.

Study Details

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.

Key Dates

Start date
Nov 5, 2021
Status verified
Mar 2022
Primary completion
Dec 24, 2021
Completion
Dec 24, 2021

Study Design

Enrollment
7 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Period 1: Enpatoran + [14C]enpatoran microtracer
  • Experimental: Period 2: Enpatoran + [14C]enpatoran microdose

Primary Outcome Measure

Period 1: Percent Urinary Recovery (feurine) of Total Radioactivity per Sampling Interval [ Time Frame: -24-0 hours (pre-dose), 0-4, 4-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours after the initiation of the intravenous (IV) dose ]

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