SINGLE-CENTER, SINGLE DOSE ORAL EXCRETION BALANCE STUDY OF RO5200628 IN HEALTHY MALE VOLUNTEERS

SINGLE-CENTER, SINGLE DOSE ORAL EXCRETION BALANCE STUDY OF RO5200628 IN HEALTHY MALE VOLUNTEERS - [14C]-RO5200628 ADME study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34612

Enrollment

Registered

2010-08-23

Start date

2010-09-01

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

depression Major depressive disorder

Interventions

Active substance: RO5200628

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age: between18 and 65 years of age; 2. BMI: between 18 and 30 kg/m2; 3. Non-smoker and moderate smokers

Exclusion criteria

Exclusion criteria: 1. History of any clinically significant hematological, hepatic, gastro-intestinal, endocrine, respiratory, cardiovascular, renal, urogenital, central nervous system (CNS), allergic, ophthalmologic disease, metabolic disorder, cancer or cirrhosis. 2. Diseases or surgical or medical conditions that are capable of altering the absorption, metabolism or elimination of drugs or of constituting a risk factor when taking the study drug in the judgment of the investigator. 3. Presence or history of any medically diagnosed, clinically significant psychiatric disorder

Design outcomes

Primary

Measure	Time frame
The primary study variable is the urinary and fecal recovery of total radioactivity.	—

Secondary

Measure	Time frame
All other kinetic parameters and the safety data will be regarded as secondary.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)