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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01181024
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic, Healthy Volunteer Drug: Placebo Drug: RO5303253 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official 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
Study Start Date : April 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: A: HV ascending dose Drug: Placebo
matching RO5303253 placebo, administered as single dose (Parts A + B) or multiple dose (Part C)

Drug: RO5303253
Cohorts receiving single ascending doses
Experimental: B: HV food effect Drug: Placebo
matching RO5303253 placebo, administered as single dose (Parts A + B) or multiple dose (Part C)

Drug: RO5303253
Single dose
Experimental: C: Hepatitis C Drug: Placebo
matching RO5303253 placebo, administered as single dose (Parts A + B) or multiple dose (Part C)

Drug: RO5303253
Multiple doses


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability: Adverse events, laboratory parameters, ECG, blood pressure [ Time Frame: approximately 6 months ]
  2. Pharmacokinetics: Plasma and urine concentrations of RO5303253 and its main metabolite RO1080713 [ Time Frame: approximately 6 months ]

Secondary Outcome Measures :
  1. Effect of food intake on pharmacokinetics in healthy volunteers [ Time Frame: Days 1-4 ]
  2. Pharmacodynamics (viral responses) and drug resistance profiling in chronic hepatitis C patients [ Time Frame: From baseline to Day 15 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181024


Locations
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New Zealand
Grafton, New Zealand, 1010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01181024    
Other Study ID Numbers: PP25195
2009-018183-96
First Posted: August 13, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic