Healthy Patient Study Clinical Trial
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | July 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Area under the plasma concentration-time curve from 0-t (AUC0-t) | Within 29 days | No | |
| Primary | Maximum observed plasma concentration (Cmax) | Within 29 days | No | |
| Primary | Time to maximum observed plasma concentration (Tmax) | Within 29 days | No | |
| Secondary | Change from baseline in QTcF | Up to 29 days | No | |
| Secondary | Incidence of adverse events | Within 43 days | No | |
| Secondary | Clinically significant changes from baseline in physical examination or laboratory parameters | Within 29 days | No | |
| Secondary | Mean model parameters of RG1662 concentration vs. QTcF changes | Within 29 days | No |