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

Hepatitis C, Chronic, Healthy Volunteer Clinical Trial

Official title:

A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of the HCV Nucleoside Inhibitor RO5428029 in Healthy Subjects and in CHC Genotype 1 Infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371162
• Other study ID #: NP25733
• Status: Completed
• Phase: Phase 1
• First received: June 6, 2011
• Last updated: November 1, 2016
• Start date: June 2011
• Est. completion date: December 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: AFSSAPS
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis C, Chronic, Healthy Volunteer

Intervention

Drug:
• RO5428029
Multiple ascending doses
• placebo
multiple doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

France,  Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part B: Viral load response: HCV RNA (assessed by Roche COBAS Taqman HCV Test)		up to 17 days	No
Primary	Parts A + B: Safety: Incidence of adverse events		up to 24 days	No
Primary	Parts A + B: Pharmacokinetics: Area under the concentration - time curve (AUC)		up to 24 days	No
Secondary	Part B: Viral resistance (viral breakthrough/non-response/partial response) HCV RNA assessed by Roche COBAS Paqman HCV Test		up to 17 days	No