Single-center, open-label, non-randomized study investigating the excretion balance, pharmacokinetics and metabolism of a single oral dose of [14C]-labeled RO5285119 in healthy male subjects

Single-center, open-label, non-randomized study investigating the excretion balance, pharmacokinetics and metabolism of a single oral dose of [14C]-labeled RO5285119 in healthy male subjects - RO5285119 mass balance study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41196

Enrollment

Registered

2014-05-15

Start date

2014-06-02

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

ASD Asperger's syndrome Autism Disorder

Interventions

During the study the volunteer will receive the study medication after an overnight fast (at least 8 hours) as an oral solution of 10 milliliters. After administration of the study medication, the v

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 35-64 yrs, inclusive BMI: 18.0 - 30.0 kg/m2, inclusive

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
To characterize the routes and rates of elimination of [14C]-labeled RO5285119 To assess the pharmacokinetics of total drug related material, RO5285119 and its metabolite(s) as appropriate	—

Secondary

Measure	Time frame
To identify and quantify the metabolic profiles of RO5285119 in plasma, feces and urine, based on radioactive metabolic profiling, and characterize any major metabolite(s) To explore the safety and tolerability of a single dose of RO5285119 in healthy volunteers	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)