Single-center, open label, multiple dose study to investigate the pharmacokinetics of RO5186582 given BID over 28 days, and in addition, the excretion and metabolism of [13C]- labelled IV microdoses and an oral [14C]-labelled dose of RO5186582 in Healthy Male Volunteers

Single-center, open label, multiple dose study to investigate the pharmacokinetics of RO5186582 given BID over 28 days, and in addition, the excretion and metabolism of [13C]- labelled IV microdoses and an oral [14C]-labelled dose of RO5186582 in Healthy Male Volunteers - [13C]- and [14C]-RO5186582 absolute bioavailability study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36981

Enrollment

Registered

2012-08-01

Start date

2012-08-16

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Down Syndrome trisomy 21

Interventions

Oral Treatments: Days 1-27 160mg RO5186852 orally as 4x40mg tablets twice daily (Day 1: evening only) Day 1 morning only 160mg RO5186852 single dose as capsule [14C]-labelled RO5186582 containing 2.8

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male 30-55 yrs, inclusive BMI: 18.0-30.0 kg/m2, inclusive non-smoking or smoking

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
Plasma levels of RO5186582 and its metabolites as appropriate, will be determined. Plasma concentrations will be determined by a validated assay. The stable isotope [13C]-labelled RO5186582 and RO5271857 will be measured in plasma by a specific LC/MS-MS method. Radioactivity concentrations in blood, plasma, urine and feces will be determined by conventional methods and AMS as appropriate.	—

Secondary

Measure	Time frame
adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination, C-SSRS and Leeds Sleep Questionnaire	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)