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Clinical Trials/NCT01418274
NCT01418274CompletedPhase 1

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

Hoffmann-La Roche0 sites20 target enrollmentStarted: August 2011Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
20
Primary Endpoint
Change in area under the plasma concentration time curve (AUC) of escitalopram
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Single arm

Experimental

Intervention: escitalopram (Drug)

Single arm

Experimental

Intervention: danoprevir (Drug)

Single arm

Experimental

Intervention: ritonavir (Drug)

Outcomes

Primary Outcomes

Change in area under the plasma concentration time curve (AUC) of escitalopram

Time Frame: Approximately 4 weeks

Secondary Outcomes

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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