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

NCT ID: NCT01418274

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-09-30

Brief Summary

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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

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

oral doses of danoprevir

escitalopram

Intervention Type DRUG

oral doses of escitalopram

ritonavir

Intervention Type DRUG

oral doses of ritonavir

Interventions

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danoprevir

oral doses of danoprevir

Intervention Type DRUG

escitalopram

oral doses of escitalopram

Intervention Type DRUG

ritonavir

oral doses of ritonavir

Intervention Type DRUG

Eligibility 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Lenexa, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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NP25643

Identifier Type: -

Identifier Source: org_study_id