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

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 - [14C]-UCB0942 ADME study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35304

Enrollment

Registered

2011-12-07

Start date

2011-12-13

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

epilepsy neurological disorder

Interventions

Study Medication Active substance: [14C]-UCB0942 Activity: Indication: epilepsy Strength: 100 mg Dosage form: drinking solution Treatment: A single oral dose of 100 mg [14C]-UCB0842, containing appr

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: Total radioactivity in plasma, urine, feces and expired air, plasma UCB0942 concentrations, pharmacokinetic parameters and metabolite profiling Safety: adverse evebts, vital signs, ECG and holter ECG, clinical laboratory parameters	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)