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

• ClinicalTrials.gov Identifier: NCT01418274
• Recruitment Status: Completed
• First Posted: August 17, 2011
• Last Update Posted: November 2, 2016
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Tracking Information

• First Submitted Date: July 20, 2011
• First Posted Date: August 17, 2011
• Last Update Posted Date: November 2, 2016
• Study Start Date: August 2011
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 29, 2011): Change in area under the plasma concentration time curve (AUC) of escitalopram [ Time Frame: Approximately 4 weeks ]
• Original Primary Outcome Measures (submitted: August 16, 2011): Effect of danoprevir/ritonavir on single dose pharmacokinetics of escitalopram: change in area under the plasma concentration time curve (AUC) of escitalopram [ Time Frame: Approximately 4 weeks ]
• Change History: Complete list of historical versions of study NCT01418274 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: August 16, 2011)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Effect of Danoprevir/Ritonavir on the Pharmacokinetics of Escitalopram and S-Demethylcitalopram in Healthy Volunteers
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Healthy Volunteer

Intervention

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

Study Arms

Experimental: Single arm

Interventions:

• Drug: danoprevir
• Drug: escitalopram
• Drug: ritonavir

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 16, 2011): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 2011
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01418274
• Other Study ID Numbers: NP25643
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Hoffmann-La Roche
• Study Sponsor: Hoffmann-La Roche
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

• PRS Account: Hoffmann-La Roche
• Verification Date: November 2016