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A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers

NCT ID: NCT01654211

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

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-11-30

Brief Summary

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This three-part study will evaluate the pharmacokinetics and bioavailability of intravenous danoprevir with and without low-dose oral ritonavir, and the effect of oral cyclosporine on the pharmacokinetics of intravenous danoprevir with ritonavir in healthy volunteers.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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Part 1: iv danoprevir

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

single iv infusion

ritonavir

Intervention Type DRUG

oral doses

Part 1: placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

single iv infusion

ritonavir

Intervention Type DRUG

oral doses

Part 2 A: iv danoprevir

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

single iv infusion

ritonavir

Intervention Type DRUG

oral doses

Part 2 B: oral danoprevir

Group Type ACTIVE_COMPARATOR

danoprevir

Intervention Type DRUG

single oral dose

ritonavir

Intervention Type DRUG

oral doses

Part 2 C: ritonavir

Group Type ACTIVE_COMPARATOR

ritonavir

Intervention Type DRUG

oral doses

Part 3 D: iv danoprevir

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

single iv infusion

ritonavir

Intervention Type DRUG

oral doses

Part 3 E: iv danoprevir + cyclosporine

Group Type EXPERIMENTAL

danoprevir

Intervention Type DRUG

single iv infusion

ritonavir

Intervention Type DRUG

oral doses

Interventions

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danoprevir

single iv infusion

Intervention Type DRUG

danoprevir

single oral dose

Intervention Type DRUG

placebo

single iv infusion

Intervention Type DRUG

ritonavir

oral doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult healthy male and female nonsmoking volunteers, 18 to 55 years of age inclusive; healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination

Exclusion Criteria

* Pregnant or lactating women or males with female partners who are pregnant or lactating
* Positive results for drugs of abuse at screening or prior to admission to the clinical site during any study period
* Positive for hepatitis B, hepatitis C or HIV infection
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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Zuidlaren, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2012-000470-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NP28297

Identifier Type: -

Identifier Source: org_study_id