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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02604355




Registration number
NCT02604355
Ethics application status
Date submitted
10/11/2015
Date registered
13/11/2015
Date last updated
25/05/2017

Titles & IDs
Public title
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7020322 Following Oral Administration in Healthy Participants and Chronic Hepatitis B Patients
Scientific 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
Secondary ID [1] 0 0
BP29948
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Matching Placebo
Treatment: Drugs - RO7020322

Experimental: Healthy Participants (Multiple-Ascending Dosing) -

Experimental: Healthy Participants (Single-Ascending Dosing) -

Experimental: Healthy Participants (Study of Food Effect) -

Experimental: Participants with Chronic Hepatitis B (Proof of mechanism) -


Other interventions: Matching Placebo
Oral dosing with placebo capsules to match RO7020322.

Treatment: Drugs: 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 code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events
Timepoint [1] 0 0
Up to 8 weeks
Primary outcome [2] 0 0
Intensity of adverse events
Timepoint [2] 0 0
Up to 8 weeks
Primary outcome [3] 0 0
Number of participants with clinically significant laboratory abnormalities
Timepoint [3] 0 0
Up to 8 weeks
Primary outcome [4] 0 0
Number of participants with clinically significant electrocardiogram (ECG) abnormalities
Timepoint [4] 0 0
Up to 8 weeks
Primary outcome [5] 0 0
Number of participants with clinically significant vital signs abnormalities
Timepoint [5] 0 0
Up to 8 weeks
Secondary outcome [1] 0 0
Maximum observed plasma concentration (Cmax) of RO7020322
Timepoint [1] 0 0
Up to 18 days
Secondary outcome [2] 0 0
Time from dosing to Cmax (Tmax) of RO7020322
Timepoint [2] 0 0
Up to 18 days
Secondary outcome [3] 0 0
Trough plasma concentrations (Ctrough) of RO7020322
Timepoint [3] 0 0
Up to 18 days
Secondary outcome [4] 0 0
Area under the plasma concentration-time curve between time zero (pre-dose) and the time of the last quantifiable concentration (AUClast) of RO7020322
Timepoint [4] 0 0
Up to 18 days
Secondary outcome [5] 0 0
Area under the plasma concentration-time curve between time zero (pre-dose) extrapolated to infinity (AUC0-Inf) of RO7020322
Timepoint [5] 0 0
Up to 18 days
Secondary outcome [6] 0 0
Apparent clearance (CL/F) of RO7020322
Timepoint [6] 0 0
Up to 18 days
Secondary outcome [7] 0 0
Apparent volume (V/F) of RO7020322
Timepoint [7] 0 0
Up to 18 days
Secondary outcome [8] 0 0
Apparent terminal phase half-life (t1/2) of RO7020322
Timepoint [8] 0 0
Up to 18 days
Secondary outcome [9] 0 0
Area under the plasma concentration-time curve (AUC0-t,ss) of RO7020322 at steady state
Timepoint [9] 0 0
Up to 18 days
Secondary outcome [10] 0 0
Area under the plasma concentration-time curve (AUC0-t) of RO7020322 on Day 1
Timepoint [10] 0 0
Up to 18 days
Secondary outcome [11] 0 0
Plasma concentration of hepatitis B surface antigen (HBsAg)
Timepoint [11] 0 0
Up to 8 weeks

Eligibility
Key inclusion criteria
Healthy Participants'

- 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'

- 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Healthy Participants'

- 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'

- 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

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/05/2016
Sample size
Target
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
New Zealand
State/province [2] 0 0
Grafton
Country [3] 0 0
New Zealand
State/province [3] 0 0
Tauranga
Country [4] 0 0
Taiwan
State/province [4] 0 0
Kaohsiung

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02604355
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02604355