A Study on Safety, Tolerability and Pharmacokinetics of RO5303253 in Healthy Volunteers and Patients With Chronic Hepatitis C Genotype 1
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ClinicalTrials.gov Identifier: NCT01181024 |
Recruitment Status :
Completed
First Posted : August 13, 2010
Last Update Posted : November 2, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C, Chronic, Healthy Volunteer | Drug: Placebo Drug: RO5303253 | Phase 1 |
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 |

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

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

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
New Zealand | |
Grafton, New Zealand, 1010 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
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 |
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 |