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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 January 2013 |
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Main ID: |
NCT01418274 |
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Date of registration:
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20/07/2011 |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01418274 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy Volunteer
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Intervention(s)
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Drug: danoprevir
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Drug: escitalopram
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Drug: ritonavir
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Primary Outcome(s)
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Change in area under the plasma concentration time curve (AUC) of escitalopram
[Time Frame: Approximately 4 weeks]
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Secondary Outcome(s)
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Effect of co-administration of escitalopram on danoprevir/ritonavir steady-state pharmacokinetics: change in AUC of danoprevir/ritonavir
[Time Frame: Approximately 4 weeks]
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Effect on pharmacokinetics of major escitalopram metabolite: change in AUC of S-demethylcitalopram
[Time Frame: Approximately 4 weeks]
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Safety: Incidence of adverse events
[Time Frame: Approximately 6 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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