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

Completed · Phase 1

Conditions studied: Healthy Volunteer

In brief

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.

Key facts

Study ID

NCT01418274

Run by

Hoffmann-La Roche

People needed

20

Starts

2011-08-01

Expected to finish

2011-09-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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