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

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

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  (Clinical Trial)
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 : August 2011
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 [ Time Frame: Approximately 4 weeks ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418274


Locations
United States, Kansas
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01418274     History of Changes
Other Study ID Numbers: NP25643
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Ritonavir
Lactams
Citalopram
Dexetimide
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists