A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7020322 Following Oral Administration in Healthy Participants and Chronic Hepatitis B Patients

NCT ID: NCT02604355

Last Updated: 2017-05-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-28
• Study Completion Date: 2016-05-09

Brief Summary

This is a multiple-center, randomized, double-blind, placebo-controlled, single-ascending dose and multiple-ascending dose, adaptive parallel study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020322 following oral administration in healthy participants and chronic hepatitis B patients.

Conditions

Hepatitis B, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Healthy Participants (Multiple-Ascending Dosing)

Group Type: EXPERIMENTAL

Matching Placebo

Intervention Type: OTHER

Oral dosing with placebo capsules to match RO7020322.

RO7020322

Intervention Type: DRUG

Adaptive oral dosing with RO7020322 capsules, starting at 1 mg daily, with ascending or adjusted dosing based on the results of previous dosing.

Healthy Participants (Single-Ascending Dosing)

Group Type: EXPERIMENTAL

Matching Placebo

Intervention Type: OTHER

Oral dosing with placebo capsules to match RO7020322.

RO7020322

Intervention Type: DRUG

Adaptive oral dosing with RO7020322 capsules, starting at 1 mg daily, with ascending or adjusted dosing based on the results of previous dosing.

Healthy Participants (Study of Food Effect)

Group Type: EXPERIMENTAL

Matching Placebo

Intervention Type: OTHER

Oral dosing with placebo capsules to match RO7020322.

RO7020322

Intervention Type: DRUG

Adaptive oral dosing with RO7020322 capsules, starting at 1 mg daily, with ascending or adjusted dosing based on the results of previous dosing.

Participants with Chronic Hepatitis B (Proof of mechanism)

Group Type: EXPERIMENTAL

Matching Placebo

Intervention Type: OTHER

Oral dosing with placebo capsules to match RO7020322.

RO7020322

Intervention Type: DRUG

Adaptive oral dosing with RO7020322 capsules, starting at 1 mg daily, with ascending or adjusted dosing based on the results of previous dosing.

Interventions

Matching Placebo

Oral dosing with placebo capsules to match RO7020322.

Intervention Type: OTHER

RO7020322

Adaptive oral dosing with RO7020322 capsules, starting at 1 mg daily, with ascending or adjusted dosing based on the results of previous dosing.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• A Body Mass Index (BMI) between 18 to 30 kg/m^2, inclusive, and a body weight of at least 50 kg
• Males must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm during the study
• Women should be of non-childbearing potential
• Able to comply with study restrictions
• Non-smoker (nor tobacco-containing products) for at least 90 days prior to dosing on Day 1 and agreeing not to smoke during the study

• Chronic hepatitis B infection
• A BMI between 18 to 32 kg/m^2, inclusive
• Positive test for HBsAg for more than 6 months prior to randomization
• On entecavir or tenofovir treatment for at least 6 months prior to randomization and remaining on stable treatment during the study
• Liver biopsy, fibroscan® or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic hepatitis B (HBV) infection without evidence of bridging fibrosis or cirrhosis
• Males must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm during the study
• Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use non-hormonal contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least until the end of the follow-up period

Exclusion Criteria

• Women who are lactating
• Any suspicion or history of alcohol and/or other substance abuse or dependence in the past 6 months
• Positive urine drug and alcohol screen (barbiturates, benzodiazepines, methadone, amphetamines, methamphetamines, opiates, cocaine, cannabinoids, and alcohol), or positive cotinine test at Day -1
• Positive result on HBV, hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 and 2
• A personal history of unexplained blackouts or faints, or known risk factors for Torsade de Pointes
• Clinically significant abnormalities (as judged by the Investigator) in the physical examination and in the laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis) at screening and on Day -1
• Participation in an investigational drug or device study within 90 days prior to screening or 5 times the half-life of the investigational drug (whichever is longer)
• Donation of blood over 500 mL within three months prior to screening
• Concomitant disease or condition (including allergic reactions against any drug, or multiple allergies) that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the healthy participant in this study

• Women who are pregnant (positive pregnancy test) or lactating
• History or other evidence of bleeding from esophageal varices
• Decompensated liver disease
• History or other evidence of a medical condition associated with chronic liver disease other than HBV infection
• Documented history or other evidence of metabolic liver disease within one year of randomization
• Positive test for hepatitis A (IgM anti-HAV), hepatitis C, or HIV
• Documented history of infection with hepatitis D virus
• Expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study, with the exception of oral therapy for herpes simplex virus (HSV) I or HSV II
• History of immunologically-mediated disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Queen Mary Hospital

Hong Kong, , Hong Kong

Auckland Clinical Studies Limited

Grafton, , New Zealand

Tauranga Hospital

Tauranga, , New Zealand

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Countries

Hong Kong; New Zealand; Taiwan

Other Identifiers

BP29948

Identifier Type: -

Identifier Source: org_study_id