A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C

Phase 1

Completed

• Conditions: Hepatitis C, Chronic, Healthy Volunteer
• Interventions: Drug: RO5428029; Drug: placebo

• Registration Number: NCT01371162
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This 2-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with hepatitis C infection. Cohorts will be randomized to receive either RO5428029 in ascending doses or placebo for up to 7 days (patients) or up to 14 days (healthy volunteers).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-06
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-10
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Healthy subjects (Part A) or patients with chronic hepatitis C infection (Part B), 18 to 60 years of age, inclusive
• Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a minimum weight of 45 kg
• Female subjects/patients must be surgically sterile or post-menopausal
• Male subjects/patients and their partners of childbearing potential must use 2 methods of contraception
• For HCV patients:
• Hepatitis C genotype 1 of > 6 months duration at screening
• HCV RNA quantifiable (Roche COBAS TaqMan HCV Test) at screening
• HCV treatment-naïve (no prior antiviral therapy for chronic hepatitis C with interferon-based therapy)
• Liver biopsy or non-invasive procedure within the past 2 years showing absence of cirrhosis

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Exclusion Criteria

• Pregnant or lactating women, and male partners of women who are pregnant or lactating
• Positive test for drugs of abuse
• History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams or 1 unit of alcohol
• History or symptoms of any significant disease or disorder
• History of active malignancy within the last 5 years, except for localized or in situ carcinoma (e.g. basal or squamous cell carcinoma of the skin)
• Positive for hepatitis B or HIV infection, and/ or for HCV for healthy volunteers (Part A)
• For HCV patients:
• Decompensated liver disease or impaired liver function as defined by any history of ascites, hepatic encephalopathy, hepatocellular carcinoma or bleeding esophageal varices, or prothrombin international normalized ratio (PTINR) >/= 2.0 at screening
• Evidence of cirrhosis and/or incomplete transition to cirrhosis
• Presence or history of non-hepatitis C liver disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B1 HCV Infection	RO5428029	-
B2	placebo	-
A2	placebo	-
A1 Healthy Volunteers	RO5428029	-

Primary Outcome Measures

Name	Time	Method
Parts A + B: Pharmacokinetics: Area under the concentration - time curve (AUC)	up to 24 days
Parts A + B: Safety: Incidence of adverse events	up to 24 days
Part B: Viral load response: HCV RNA (assessed by Roche COBAS Taqman HCV Test)	up to 17 days

Secondary Outcome Measures

Name	Time	Method
Part B: Viral resistance (viral breakthrough/non-response/partial response) HCV RNA assessed by Roche COBAS Paqman HCV Test	up to 17 days