SINGLE-CENTER, OPEN-LABEL STUDY INVESTIGATING THE EXCRETION BALANCE, PHARMACOKINETICS AND METABOLISM OF A SINGLE ORAL DOSE OF [14C]-LABELED RO4917523 AND AN INTRAVENOUS TRACER DOSE OF [13C]-LABELED RO4917523 IN HEALTHY MALE VOLUNTEERS

SINGLE-CENTER, OPEN-LABEL STUDY INVESTIGATING THE EXCRETION BALANCE, PHARMACOKINETICS AND METABOLISM OF A SINGLE ORAL DOSE OF [14C]-LABELED RO4917523 AND AN INTRAVENOUS TRACER DOSE OF [13C]-LABELED RO4917523 IN HEALTHY MALE VOLUNTEERS - RO4917523 ADME study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35686

Enrollment

Registered

2011-12-23

Start date

2012-01-23

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

anxiety depressive disorders

Interventions

Treatment A single oral dose of 1 mg [12C/14C]-RO4917523 as capsule, containing approximately 2.22 MBq radiocarbon, followed by a 30 min intravenous microdose of 100 µg [13C]-RO4917523 Study medica

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age: 18 - 65 years (inclusive) BMI: 18.0 - 32.0 kg/m2 (inclusive) Gender: healthy male subjects

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
safety tolerability absorption, distribution, metabolizing and elimination	—

Secondary

Measure	Time frame
N.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)