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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01418274
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE July 20, 2011
First Posted Date  ICMJE August 17, 2011
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE August 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effect of Danoprevir/Ritonavir on the Pharmacokinetics of Escitalopram and S-Demethylcitalopram in Healthy Volunteers
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteer
Intervention  ICMJE
  • Drug: danoprevir
    oral doses of danoprevir
  • Drug: escitalopram
    oral doses of escitalopram
  • Drug: ritonavir
    oral doses of ritonavir
Study Arms  ICMJE Experimental: Single arm
Interventions:
  • Drug: danoprevir
  • Drug: escitalopram
  • Drug: ritonavir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2011)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01418274
Other Study ID Numbers  ICMJE NP25643
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP