Multiple Sclerosis
Conditions
Interventions
On Day 1
45 mg of [14C] IMU-838 as an oral solution, once
Sponsors
Immunic AG
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the mass balance (recovery), and routes and extent of elimination of a single oral dose of 45 mg [14C]-IMU-838 containing approximately 0.1998 MBq (5.4 µCi) of total radioactivity (TRA) in healthy male subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of a single oral dose of 45 mg [14C] IMU 838 containing approximately 0.1998 MBq (5.4 µCi) of TRA in healthy male subjects To further characterize the pharmacokinetics (PK) of a single oral dose of 45 mg [14C]-IMU-838 in healthy male subjects To identify and characterize metabolites of [14C]-IMU-838 in plasma, urine, and feces | — |
Countries
Netherlands
Outcome results
None listed