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

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 - RO5285119 comparative bioavailability study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44542

Enrollment

Registered

2017-08-14

Start date

2017-08-21

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Autism Spectrum Disorder

Interventions

The study will consist of 4 periods during which the volunteer will receive RO5285119 once in each period. During 3 periods, RO5285119 will be given as oral tablets and during one period as capsules

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - healthy volunteers - age 18-65 yrs, inclusive - BMI between 18.0 to 30 kg/m2

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
To investigate the relative bioavailability of the Phase 3 optimized dispersible tablet formulation versus the capsule formulation used in Phase 2 adult study	—

Secondary

Measure	Time frame
• To investigate the relative bioavailability of the Phase 3 optimized dispersible tablet formulation versus the dispersible tablet formulation used in Phase 2 pediatric study • To investigate the relative bioavailability of the Phase 3 optimized dispersible tablet formulation versus the Phase 3 dispersible tablet formulation with a coarser drug substance particle size • To investigate the relative bioavailability of the pediatric Phase 2 dispersible tablet formulation versus the capsule formulation used in Phase 2 adult study • To investigate the safety and tolerability of a single 10 mg oral dose of RO5285119 inhealthy subjects	—

Measure

Time frame

• To investigate the relative bioavailability of the Phase 3 optimized dispersible tablet formulation versus the dispersible tablet formulation used in Phase 2 pediatric study • To investigate the relative bioavailability of the Phase 3 optimized dispersible tablet formulation versus the Phase 3 dispersible tablet formulation with a coarser drug substance particle size • To investigate the relative bioavailability of the pediatric Phase 2 dispersible tablet formulation versus the capsule formulation used in Phase 2 adult study • To investigate the safety and tolerability of a single 10 mg oral dose of RO5285119 inhealthy subjects

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)