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

NCT01181024 | Completed Phase 1

• 2 other identifiers: PP251952009-018183-96
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C, Chronic, Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability: Adverse events, laboratory parameters, ECG, blood pressure

  approximately 6 months

• Pharmacokinetics: Plasma and urine concentrations of RO5303253 and its main metabolite RO1080713

  approximately 6 months

Secondary Outcomes (2)

• Effect of food intake on pharmacokinetics in healthy volunteers

  Days 1-4

• Pharmacodynamics (viral responses) and drug resistance profiling in chronic hepatitis C patients

  From baseline to Day 15

Study Arms (3)

A: HV ascending dose

EXPERIMENTAL

Drug: Placebo; Drug: RO5303253

B: HV food effect

EXPERIMENTAL

Drug: Placebo; Drug: RO5303253

C: Hepatitis C

EXPERIMENTAL

Drug: Placebo; Drug: RO5303253

Interventions

Placebo DRUG

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

A: HV ascending dose; B: HV food effect; C: Hepatitis C

RO5303253 DRUG

Cohorts receiving single ascending doses

A: HV ascending dose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Grafton, 1010, New Zealand

Location

MeSH Terms

Conditions

Hepatitis C; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 13, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

NZ (1)