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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01418274
First received: July 20, 2011
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

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 Intervention Phase
Healthy Volunteer
 Drug: danoprevir
Drug: ritonavir
Drug: escitalopram
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in area under the plasma concentration time curve (AUC) of escitalopram [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: Approximately 6 weeks ] [ Designated as safety issue: No ]
  • Effect on pharmacokinetics of major escitalopram metabolite: change in AUC of S-demethylcitalopram [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]
  • Effect of co-administration of escitalopram on danoprevir/ritonavir steady-state pharmacokinetics: change in AUC of danoprevir/ritonavir [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm Drug: danoprevir
oral doses of danoprevir
Drug: ritonavir
oral doses of ritonavir
Drug: escitalopram
oral doses of escitalopram

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01418274     History of Changes
Other Study ID Numbers: NP25643
Study First Received: July 20, 2011
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dexetimide
Citalopram
Ritonavir
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 18, 2013