A PHASE 1, OPEN-LABEL STUDY TO ASSESS THE MASS BALANCE AND PHARMACOKINETICS OF [14C]-IMU-838 IN HEALTHY MALE SUBJECTS

Completed

• Conditions: Multiple Sclerosis; 10007951

• Registration Number: NL-OMON51590
• Lead Sponsor: Immunic AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2024-01-22
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 7

Inclusion Criteria

1. Sex: Male subjects.
2. Age: 18 to 45 years, inclusive, at screening.
3. Body mass index (BMI): 18.0 to 30.0 kg/m2, inclusive, at screening.
4. Weight: >=50 kg at screening.

Exclusion Criteria

1. Previous participation in the current study.
2. Employee of ICON plc or the Sponsor.
3. History of relevant drug and/or food allergies.
4. Using tobacco products within 60 days prior to the drug administration.
5. History of alcohol abuse or drug addiction (including soft drugs like
cannabis products) in the past 2 years.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the mass balance (recovery), and routes and extent of elimination of<br /><br>a single oral dose of 45 mg [14C]-IMU-838 containing approximately 0.1998 MBq<br /><br>(5.4 µCi) of total radioactivity (TRA) in healthy male subjects</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the safety and tolerability of a single oral dose of 45 mg [14C] IMU<br /><br>838 containing approximately 0.1998 MBq (5.4 µCi) of TRA in healthy male<br /><br>subjects<br /><br><br /><br>To further characterize the pharmacokinetics (PK) of a single oral dose of 45<br /><br>mg [14C]-IMU-838 in healthy male subjects<br /><br><br /><br>To identify and characterize metabolites of [14C]-IMU-838 in plasma, urine, and<br /><br>feces</p><br>