A single-center, randomized, open-label, four-period, four-treatment, cross-over study to investigate the comparative bioavailability of dispersible tablet and capsule formulations of RO5285119 in healthy volunteers
Completed
- Conditions
- Autism Spectrum Disorder10009841
- Registration Number
- NL-OMON44542
- Lead Sponsor
- F. HoffmannLa Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
Inclusion Criteria
- healthy volunteers
- age 18-65 yrs, inclusive
- BMI between 18.0 to 30 kg/m2
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. Participation in an investigational drug or device study within 90 days prior to first dosing, or within 5 months prior to first dosing in case of a study with a biological, as calculated from the day of follow-up from the previous study. Any donation of blood over 500 mL or significant blood loss within 3 months prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To investigate the relative bioavailability of the Phase 3 optimized<br /><br>dispersible tablet formulation versus the capsule formulation used in Phase 2<br /><br>adult study</p><br>
- Secondary Outcome Measures
Name Time Method <p>• To investigate the relative bioavailability of the Phase 3 optimized<br /><br>dispersible tablet formulation versus the dispersible tablet formulation used<br /><br>in Phase 2 pediatric study<br /><br>• To investigate the relative bioavailability of the Phase 3 optimized<br /><br>dispersible tablet formulation versus the Phase 3 dispersible tablet<br /><br>formulation with a coarser drug substance particle size<br /><br>• To investigate the relative bioavailability of the pediatric Phase 2<br /><br>dispersible tablet formulation versus the capsule formulation used in Phase 2<br /><br>adult study<br /><br>• To investigate the safety and tolerability of a single 10 mg oral dose of<br /><br>RO5285119 inhealthy subjects</p><br>