A Study to Evaluate the Effect of Danoprevir/Ritonavir on the Pharmacokinetics of Escitalopram and S-Demethylcitalopram in Healthy Volunteers

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: escitalopram; Drug: ritonavir; Drug: danoprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01418274

NP25643

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Single arm

Experimental group

Treatment:

Drug: ritonavir

Drug: escitalopram

Drug: danoprevir