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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418274
• Other study ID #: NP25643
• Status: Completed
• Phase: Phase 1
• First received: July 20, 2011
• Last updated: November 1, 2016
• Start date: August 2011
• Est. completion date: September 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• danoprevir
oral doses of danoprevir
• escitalopram
oral doses of escitalopram
• ritonavir
oral doses of ritonavir

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in area under the plasma concentration time curve (AUC) of escitalopram		Approximately 4 weeks	No
Secondary	Safety: Incidence of adverse events		Approximately 6 weeks	No
Secondary	Effect on pharmacokinetics of major escitalopram metabolite: change in AUC of S-demethylcitalopram		Approximately 4 weeks	No
Secondary	Effect of co-administration of escitalopram on danoprevir/ritonavir steady-state pharmacokinetics: change in AUC of danoprevir/ritonavir		Approximately 4 weeks	No