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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01418274
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 1
• Patients Per Site Per Month: 19.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: danoprevir; Drug: escitalopram; Drug: ritonavir	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single arm	Drug: danoprevir; oral doses of danoprevir; Drug: escitalopram; oral doses of escitalopram; Drug: ritonavir; oral doses of ritonavir

Outcome Measures

Primary Outcome Measures

1. Change in area under the plasma concentration time curve (AUC) of escitalopram [Approximately 4 weeks]

Secondary Outcome Measures

1. Safety: Incidence of adverse events [Approximately 6 weeks]

2. Effect on pharmacokinetics of major escitalopram metabolite: change in AUC of S-demethylcitalopram [Approximately 4 weeks]

3. Effect of co-administration of escitalopram on danoprevir/ritonavir steady-state pharmacokinetics: change in AUC of danoprevir/ritonavir [Approximately 4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Lenexa	Kansas	United States	66219

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01418274
• Other Study ID Numbers: NP25643
• First Posted: Aug 17, 2011
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Ritonavir; Citalopram

Study Results

No Results Posted as of Nov 2, 2016