A Study to Evaluate the Effect of Danoprevir/Ritonavir on the Pharmacokinetics of Escitalopram and S-Demethylcitalopram in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Registration Number
- NCT01418274
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This single-arm, open-label, non-randomized study will evaluate the effect of danoprevir/ritonavir on the pharmacokinetics of escitalopram and S-demethylcitalopram in healthy volunteers. Healthy volunteers will receive oral doses of danoprevir/ritonavir and escitalopram. The anticipated time of the study is 6 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Adult healthy volunteers, aged 18 to 55 years, inclusive
- Body mass index (BMI) 18.0 to 32.0 kg, inclusive
- Absence of evidence of any active or chronic disease
- Non-smokers
Exclusion Criteria
- Presence of any active or chronic disease
- Abnormal blood pressure
- Abnormal resting heart rate
- Abnormal ECG values
- History of any clinically significant cardiovascular or cerebrovascular disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm danoprevir - Single arm escitalopram - Single arm ritonavir -
- Primary Outcome Measures
Name Time Method Change in area under the plasma concentration time curve (AUC) of escitalopram Approximately 4 weeks
- Secondary Outcome Measures
Name Time Method Effect on pharmacokinetics of major escitalopram metabolite: change in AUC of S-demethylcitalopram Approximately 4 weeks Safety: Incidence of adverse events Approximately 6 weeks Effect of co-administration of escitalopram on danoprevir/ritonavir steady-state pharmacokinetics: change in AUC of danoprevir/ritonavir Approximately 4 weeks