A single-center, open-label study of excretion balance, pharmacokinetics, and metabolism of 14carbon-labeled UCB0942 after 100 mg single oral dose administration in healthy male subjects

Completed

• Conditions: epilepsy; neurological disorder; 10039911

• Registration Number: NL-OMON35304
• Lead Sponsor: CB Celltech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

- healthy male subjects
- 18-55 yrs, inclusive
- BMI:18-30 kg/m2, inclusive, and weighs at least 50 kg
- non-smoker

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics: Total radioactivity in plasma, urine, feces and expired air,<br /><br>plasma UCB0942 concentrations, pharmacokinetic parameters and metabolite<br /><br>profiling<br /><br>Safety: adverse evebts, vital signs, ECG and holter ECG, clinical laboratory<br /><br>parameters</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n/a</p><br>