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

A Study to Investigate the Effect of Multiple Doses of Danoprevir/Ritonavir (DNV/RTV) on the Pharmacokinetics (PK) of Escitalopram (ESC) and S-Demethylcitalopram (S-DCT) in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01418274

Enrollment

Registered

2011-08-17

Start date

2011-08-31

Completion date

2011-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGdanoprevir

oral doses of danoprevir

DRUGescitalopram

oral doses of escitalopram

DRUGritonavir

oral doses of ritonavir

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change in area under the plasma concentration time curve (AUC) of escitalopram	Approximately 4 weeks

Secondary

Measure	Time frame
Safety: Incidence of adverse events	Approximately 6 weeks
Effect on pharmacokinetics of major escitalopram metabolite: change in AUC of S-demethylcitalopram	Approximately 4 weeks
Effect of co-administration of escitalopram on danoprevir/ritonavir steady-state pharmacokinetics: change in AUC of danoprevir/ritonavir	Approximately 4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026