A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RG1662 in Healthy Subjects

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is being conducted to investigate the effect of itraconazole treatment in the pharmacokinetics of RG1662. It is also to evaluate the exposure of RG1662 vs. QTc response relationship and the safety and tolerability of RG1662 when given in combination with itraconazole in healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Hydroxyitraconazole; Itraconazole

Criteria

Inclusion Criteria:

• Male or female volunteers

• Ages 18 to 60 years, inclusive

• A body mass index (BMI) between 18 to 32 kg/m2, inclusive

• Agreement to comply with study restrictions

Exclusion Criteria:

• History of epilepsy, convulsions or significant head injury or electroencephalogram (EEG) abnormalities

• Electrocardiogram (EGC) or vital signs abnormalities

• Significant history of drug allergy, as determined by the Investigator, or a known hypersensitivity to any of the ingredients of any of the study treatments

• Use of any drugs or substances that are known to be substrates, inducers or inhibitors of CYP3A4 within 30 days of the first dose administration

• Pregnant or lactating

• Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions