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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01181024




Registration number
NCT01181024
Ethics application status
Date submitted
12/08/2010
Date registered
13/08/2010
Date last updated
2/11/2016

Titles & IDs
Public title
A Study on Safety, Tolerability and Pharmacokinetics of RO5303253 in Healthy Volunteers and Patients With Chronic Hepatitis C Genotype 1
Scientific title
A Single Ascending Dose Tolerability and Pharmacokinetic Study of RO5303253 With a Pilot Food-effect Investigation in Healthy Subjects and Exploratory Pharmacokinetic, Pharmacodynamic, and Safety Assessments in Chronic Hepatitis C Genotype 1 Patients Following 5 Days of Oral Administration
Secondary ID [1] 0 0
2009-018183-96
Secondary ID [2] 0 0
PP25195
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic, Healthy Volunteer 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - RO5303253
Treatment: Drugs - RO5303253
Treatment: Drugs - RO5303253

Experimental: A: HV ascending dose -

Experimental: B: HV food effect -

Experimental: C: Hepatitis C -


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

Treatment: Drugs: RO5303253
Cohorts receiving single ascending doses

Treatment: Drugs: RO5303253
Single dose

Treatment: Drugs: RO5303253
Multiple doses
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability: Adverse events, laboratory parameters, ECG, blood pressure
Timepoint [1] 0 0
approximately 6 months
Primary outcome [2] 0 0
Pharmacokinetics: Plasma and urine concentrations of RO5303253 and its main metabolite RO1080713
Timepoint [2] 0 0
approximately 6 months
Secondary outcome [1] 0 0
Effect of food intake on pharmacokinetics in healthy volunteers
Timepoint [1] 0 0
Days 1-4
Secondary outcome [2] 0 0
Pharmacodynamics (viral responses) and drug resistance profiling in chronic hepatitis C patients
Timepoint [2] 0 0
From baseline to Day 15

Eligibility
Key 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
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2010
Sample size
Target
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Grafton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01181024
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01181024