drugset / Trial / NCT02254759

A Study of RO5186582 Treatment on Cytochrome P450 (CYP) 3A4 Activity in Healthy Participants

NCT02254759 ↗

Phase 1 Completed 12 enrolled Hoffmann-La Roche
Non-randomizedCrossoverOpen-label

Summary

This is a non-randomized, open-label, five treatment, fixed sequence cross-over study to investigate the effect of RO5186582 treatment on CYP3A activity using midazolam as a probe CYP3A substrate, and also to assess the pharmacodynamic measures of brain electrical activity and sedation to explore the pharmacodynamic interaction between the gama-amino butyric acid (GABA)A negative allosteric modulator RO5186582 and the prototypical GABAA positive allosteric modulator midazolam. The anticipated study duration is up to nine weeks.

Timeline

Start
2014-10
Primary completion
2014-11
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Basmisanil Small molecule 240 mg Oral
Subject Midazolam Small molecule 1 mg Intravenous
Subject Midazolam Small molecule 5 mg Oral

Indications

No indication recorded.