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A Study on Safety, Tolerability and Pharmacokinetics of RO5303253 in Healthy Volunteers and Patients With Chronic Hepatitis C Genotype 1

NCT ID: NCT01181024

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

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-10-31

Brief Summary

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This randomized, double-blind, placebo controlled, 3 part study will assess the safety, tolerability and pharmacokinetics of RO5303253 in healthy volunteers and patients with chronic hepatitis C genotype 1. In Part A, cohorts of healthy volunteers will be randomized to receive single ascending doses of RO5303253 or placebo. In Part 2, healthy volunteers will receive a single dose of RO5303253 or placebo in a cross-over design (with a washout period of at least 7 days) to assess food effects on pharmacokinetics. In Part 3, patients with chronic hepatitis C will be randomized ro receive either RO5303253 or placebo for 5 days.

Detailed Description

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Conditions

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Hepatitis C, Chronic, Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A: HV ascending dose

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

matching RO5303253 placebo, administered as single dose (Parts A + B) or multiple dose (Part C)

RO5303253

Intervention Type DRUG

Cohorts receiving single ascending doses

B: HV food effect

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

matching RO5303253 placebo, administered as single dose (Parts A + B) or multiple dose (Part C)

RO5303253

Intervention Type DRUG

Single dose

C: Hepatitis C

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

matching RO5303253 placebo, administered as single dose (Parts A + B) or multiple dose (Part C)

RO5303253

Intervention Type DRUG

Multiple doses

Interventions

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Placebo

matching RO5303253 placebo, administered as single dose (Parts A + B) or multiple dose (Part C)

Intervention Type DRUG

RO5303253

Cohorts receiving single ascending doses

Intervention Type DRUG

RO5303253

Single dose

Intervention Type DRUG

RO5303253

Multiple doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers or patients with chronic hepatitis C genotype 1, 18 to 60 years of age
* Patients must be treatment-naïve for antiviral therapy for chronic hepatitis C with interferon based therapy
* Body mass index (BMI) 18 - 32 kg/m2 inclusive, minimum weight 45 kg
* Females must be surgically sterile or menopausal
* Male subjects and their partners of childbearing potential must use 2 methods of contraception throughout the study and for 70 days after the last dose

Exclusion Criteria

* Pregnant or lactating women and male partners of women who are pregnant or lactating
* Women with reproductive potential
* Positive for hepatitis B or HIV (or hepatitis C for healthy volunteers) at screening
* For hepatitis C patients: decompensated liver disease or impaired liver function, evidence of cirrhosis documented at any time, presence or history of non-hepatitis C chronic liver disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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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Grafton, , New Zealand

Site Status

Countries

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Argentina Romania New Zealand

Other Identifiers

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2009-018183-96

Identifier Type: -

Identifier Source: secondary_id

PP25195

Identifier Type: -

Identifier Source: org_study_id