Trial record 45 of 511 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02604355
First received: November 10, 2015
Last updated: August 1, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Hepatitis B, Chronic
Other: Matching Placebo
Drug: RO7020322
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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 Subjects and Chronic Hepatitis B Patients

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Intensity of adverse events [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant laboratory abnormalities [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant electrocardiogram (ECG) abnormalities [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant vital signs abnormalities [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum observed plasma concentration (Cmax) of RO7020322 [ Time Frame: Up to 18 days ] [ Designated as safety issue: No ]
  • Time from dosing to Cmax (Tmax) of RO7020322 [ Time Frame: Up to 18 days ] [ Designated as safety issue: No ]
  • Trough plasma concentrations (Ctrough) of RO7020322 [ Time Frame: Up to 18 days ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve between time zero (pre-dose) and the time of the last quantifiable concentration (AUClast) of RO7020322 [ Time Frame: Up to 18 days ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve between time zero (pre-dose) extrapolated to infinity (AUC0-Inf) of RO7020322 [ Time Frame: Up to 18 days ] [ Designated as safety issue: No ]
  • Apparent clearance (CL/F) of RO7020322 [ Time Frame: Up to 18 days ] [ Designated as safety issue: No ]
  • Apparent volume (V/F) of RO7020322 [ Time Frame: Up to 18 days ] [ Designated as safety issue: No ]
  • Apparent terminal phase half-life (t1/2) of RO7020322 [ Time Frame: Up to 18 days ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve (AUC0-t,ss) of RO7020322 at steady state [ Time Frame: Up to 18 days ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve (AUC0-t) of RO7020322 on Day 1 [ Time Frame: Up to 18 days ] [ Designated as safety issue: No ]
  • Plasma concentration of hepatitis B surface antigen (HBsAg) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 165
Study Start Date: November 2015
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy Participants (Multiple-Ascending Dosing) Other: Matching Placebo
Oral dosing with placebo capsules to match RO7020322.
Drug: RO7020322
Adaptive oral dosing with RO7020322 capsules, starting at 1 mg daily, with ascending or adjusted dosing based on the results of previous dosing.
Experimental: Healthy Participants (Single-Ascending Dosing) Other: Matching Placebo
Oral dosing with placebo capsules to match RO7020322.
Drug: RO7020322
Adaptive oral dosing with RO7020322 capsules, starting at 1 mg daily, with ascending or adjusted dosing based on the results of previous dosing.
Experimental: Healthy Participants (Study of Food Effect) Other: Matching Placebo
Oral dosing with placebo capsules to match RO7020322.
Drug: RO7020322
Adaptive oral dosing with RO7020322 capsules, starting at 1 mg daily, with ascending or adjusted dosing based on the results of previous dosing.
Experimental: Participants with Chronic Hepatitis B (Proof of mechanism) Other: Matching Placebo
Oral dosing with placebo capsules to match RO7020322.
Drug: RO7020322
Adaptive oral dosing with RO7020322 capsules, starting at 1 mg daily, with ascending or adjusted dosing based on the results of previous dosing.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy Participants' 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-Infected Participants' Inclusion Criteria:

  • 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:

Healthy Participants' 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

Chronic Hepatitis B-Infected Participants' Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02604355

Contacts
Contact: Reference Study ID Number: BP29948 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Locations
Hong Kong
Not yet recruiting
Hong Kong, Hong Kong
Not yet recruiting
Shatin, New Territories, Hong Kong
New Zealand
Recruiting
Grafton, New Zealand, 1010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02604355     History of Changes
Other Study ID Numbers: BP29948 
Study First Received: November 10, 2015
Last Updated: August 1, 2016
Health Authority: New Zealand: New Zealand Ministry of Health

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis B
Hepatitis
Hepatitis A
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on August 28, 2016