An open-label, mass balance study to investigate the absorption, metabolism and excretion of [14C]-EYP001a after a single oral dose to healthy male subjects

An open-label, mass balance study to investigate the absorption, metabolism and excretion of [14C]-EYP001a after a single oral dose to healthy male subjects - CS0315 Enyo

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48170

Enrollment

Registered

2019-06-11

Start date

2019-07-24

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic liver diseases, HBV/NASH chronic hepatitis B virus (HBV) infection and non-alcoholic steatohepatitis (NASH).

Interventions

[14C]-ENP001a, single dose

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Able to provide informed consent to participate in this study after reading the participant information sheet and informed consent form and after having the opportunity to discuss the study with the Investigator or designee. 2. Healthy and free from clinically significant illness or disease as determined by medical history, physical examination, laboratory and other tests at Screening. 3. Male Caucasian subjects, aged 18 to 60 years (inclusive) at Screening.

Exclusion criteria

Exclusion criteria: 1. Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance. 2. History or current clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders. 3. History of any major surgery within the last 4 weeks before participation in this study or any bone fracture within the last 2 months.

Design outcomes

Primary

Measure	Time frame
The following parameters will be calculated, whenever possible and appropriate and taking into account the last time point where detectable radioactivity counts were observed: Radioactivity-time profiles in whole blood and plasma. Maximum observed total radioactivity in plasma and whole blood (Cmax). Time from dosing to peak total radioactivity in plasma and whole blood (tmax). Area under the total radioactivity-time curve in plasma and whole blood from time zero to 24 hours (AUC0-24). Area under the total radioactivity-time curve in plasma and whole blood from time zero to the time of the last quantifiable drug concentration (AUC0-tz). Area under the total radioactivity-time curve in plasma and whole blood from time zero to infinity (AUC0-inf). [14C]-metabolic profile and identification of metabolites in plasma. [14C]-radioactivity in urine. [14C]-metabolic profile and identification of metabolites in urine. [14C]-radioactivity in feces. [14C]-metabolic profile and identification of metabolites in feces.	—

Measure

Time frame

The following parameters will be calculated, whenever possible and appropriate and taking into account the last time point where detectable radioactivity counts were observed: Radioactivity-time profiles in whole blood and plasma. Maximum observed total radioactivity in plasma and whole blood (Cmax). Time from dosing to peak total radioactivity in plasma and whole blood (tmax). Area under the total radioactivity-time curve in plasma and whole blood from time zero to 24 hours (AUC0-24). Area under the total radioactivity-time curve in plasma and whole blood from time zero to the time of the last quantifiable drug concentration (AUC0-tz). Area under the total radioactivity-time curve in plasma and whole blood from time zero to infinity (AUC0-inf). [14C]-metabolic profile and identification of metabolites in plasma. [14C]-radioactivity in urine. [14C]-metabolic profile and identification of metabolites in urine. [14C]-radioactivity in feces. [14C]-metabolic profile and identification of metabolites in feces.

—

Secondary

Measure	Time frame
Vital signs values; Clinical laboratory values; Number of subjects with adverse events (AEs); 12-lead ECG values.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)