A Single-Center, Open-Label, Parallel Study to Investigate the Effects of Multiple Doses of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of RO4602522 in Healthy Male Subjects.

A Single-Center, Open-Label, Parallel Study to Investigate the Effects of Multiple Doses of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of RO4602522 in Healthy Male Subjects. - RO4602522 / Ketoconazole DDI study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36948

Enrollment

Registered

2012-06-05

Start date

2012-06-12

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

Alzheimer's disease dementia

Interventions

Group 1 will receive a single dose of 15 mg study medication RO4602522 in the form of an oral tablet on Day 1. Group 2 will receive a twice daily dose of 200 mg Ketoconazole in the form of an oral

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 18-45 yrs, inclusive BMI: 18.0-30.0 kg/m2, inclusive non-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 90 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: Bloodsamples for the analysis of RO4602522 and metabolitesy will be collected during the clinic period. Urine for the analysis of RO4602522 will be collected during the clinic period at he clinic until 48 hours after dosing.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)