- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02956850
A Study in Healthy Volunteers and in Participants With Chronic Hepatitis B to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7020531
February 6, 2024 updated by: Hoffmann-La Roche
A Phase I, Sponsor-Open, Investigator-Blinded, Subject-Blinded, Multi-Center, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Administration of RO7020531: (1). Single and Multiple Ascending Doses in Healthy Male and Female Subjects; (2). 6-week Treatment of Patients With Chronic Hepatitis B Virus Infection
This sponsor-open, investigator- and participant-blinded, multi-center study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020531 in healthy participants and in participants with chronic hepatitis B. Part I will be conducted in two portions: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) which will include only healthy volunteers.
Part II will commence after completion of the MAD portion of Part I and will include only Chronic Hepatitis B (CHB) participants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sofia, Bulgaria, 1612
- COMAC Medical; Clinical Research Unit for Phase I
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Sofia, Bulgaria, 1407
- Gastroenterology department, Second clinic of internal diseases
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Hong Kong, Hong Kong, 999077
- Queen Mary Hospital
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Shatin, Hong Kong, 123456
- The Chinese University of Hong Kong
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Emilia-Romagna
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Modena, Emilia-Romagna, Italy, 41124
- Azienda Ospedaliero Universitaria Di Modena Policlinico; U.O. Farmacia
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Lombardia
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Bergamo, Lombardia, Italy, 24127
- ASST PAPA GIOVANNI XXIII; Epatologia e gastroenterologia pediatrica e dei trapianti
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Rozzano, Lombardia, Italy, 20089
- Medicina Generale ed Epatologia (Humanitas-Rozzano)
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Amsterdam, Netherlands, 1100 DD
- Academisch Medisch Centrum Universiteit Amsterdam; Dermatology and VU University Medical Center
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Auckland, New Zealand, 1142
- Auckland Clinical Studies
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Tainan, Taiwan, 70457
- National Cheng Kung University Hospital
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Taipei City, Taiwan, 112
- Taipei Veterans General Hospital
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Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital
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Xitun Dist., Taiwan, 40705
- Taichung Veterans General Hospital
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Bangkok, Thailand, 10330
- King Chulalongkorn Memorial Hospital
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Bangkok, Thailand, 10700
- Siriraj Hospital
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Chiang Mai, Thailand, 50200
- Maharaj Nakorn Chiang Mai Hospital
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Liverpool, United Kingdom, L7 8XP
- Royal Liverpool University Hospital
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London, United Kingdom, SE5 9RS
- King College Hospital NHS Foundation Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Part 1: SAD and MAD in Healthy Volunteers
- Non-smokers, or use of less than (<) 10 cigarettes (or equivalent nicotine-containing product) per day
- Negative Anti-Nuclear Antibody (ANA) test; or positive with dilutions not greater than 1:40 and with no associated history or symptoms of potential connective tissue disease or other immune-mediated diseases
Part 2: CHB Participants
- CHB infection (positive test for Hepatitis B surface antigen [HBsAg] for more than 6 months prior to randomization)
- For Cohort 1, 2, 3 and 4: HBsAg detectable at screening
- For Cohort 1, 2 and 3: Hepatitis B virus deoxyribose nuclic acid (HBV DNA) < 90 international unit per milliliter (IU/mL) for at least 6 months prior to randomization; HBV DNA < 90 IU/mL at screening by Roche Cobas assay
- For Cohort 4: HBV DNA at screening >= 2 × 10*4 IU/mL for HBeAg positive and >= 2 x 10*3 IU/mL for hepatitis B e antigen (HBeAg) negative participants
- For Cohort 1, 2 and 3: Alanine amino transferase (ALT) =<1.5 × upper limit of normal (ULN) during the 6 months prior to randomization confirmed by two measurements separated by at least 14 days; ALT at screening =< 1.5 × ULN.
- For Cohort 4: ALT and aspartate aminotransferase (AST) at screening and Day -1 visit: =< 5 × ULN.
- Negative ANA test; or positive with dilutions not greater than 1:40 and with no associated history or symptoms of potential connective tissue disease or other immune-mediated diseases
- Liver biopsy, Fibroscan® or equivalent elastography test obtained within 6 months prior to randomization demonstrating liver disease consistent with chronic HBV infection with absence of cirrhosis and absence of extensive bridging fibrosis (cirrhosis or extensive bridging fibrosis are defined as greater than or equal to (>/=) Metavir 3, recommended cut-off for Fibroscan 8.5 kilopascals [kPa])
- For Cohort 1, 2 and 3: On treatment with tenofovir, entecavir, adefovir, or telbivudine, either as single agents or in combination, for at least 6 months
- For Cohort 4: Hepatitis B virus (HBV) treatment naïve or not on any anti-HBV treatment for the past 6 months
Exclusion Criteria:
Part 1: SAD and MAD in Healthy Volunteers
- History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis, multiple sclerosis, or any other autoimmune disease); clinically significant psychiatric disease, acute infection (e.g., influenza), gastrointestinal (GI) disease (including inflammatory bowel disease, peptic ulcer disease, GI hemorrhage)
- History of having received or currently receiving any systemic anti-neoplastic (including radiation) or immune-modulatory treatment (including systemic oral or inhaled corticosteroids, IFN or pegylated interferon [PEG-IFN]) within the 8 weeks prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
- Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study
- Positive Hepatitis A virus antibody (HAV Ab IgM), HBsAg, Hepatitis C antibody (HCV Ab), or positive for human immunodeficiency virus (HIV) at screening
- History of clinically significant thyroid disease; also, participants with clinically significant elevated thyroid-stimulating hormone (TSH) concentrations at screening
- Positive results for anti-mitochondrial antibody (AMA), anti-smooth muscle antibody (ASMA) or thyroid peroxidase antibody
Part 2: CHB Participants
- History of liver cirrhosis
- History or other evidence of bleeding from esophageal varices
- Decompensated liver disease (e.g., Child-Pugh Class B or C clinical classification or clinical evidence such as ascites or varices)
- History or other evidence of a medical condition associated with chronic liver disease other than HBV infection (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, thalassemia, nonalcoholic steato-hepatitis, etc.). A clinical diagnosis of fatty liver is allowed provided that non alcoholic steatohepatitis (NASH) has been excluded by liver biopsy.
- Documented history or other evidence of metabolic liver disease within one year of randomization
- Positive test for Hepatitis A virus (IgM anti-HAV), Hepatitis C virus (HCV), Hepatitis D virus, Hepatitis E virus (HEV), or human immunodeficiency virus (HIV).
- History of or suspicion of hepatocellular carcinoma or alpha fetoprotein >/=13 nanograms per milliliter (ng/mL) at screening
- History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis, multiple sclerosis, or any other autoimmune disease); clinically significant psychiatric disease; acute infection (e.g., influenza); GI disease (including inflammatory bowel disease, peptic ulcer disease, GI hemorrhage, or history of pancreatitis); clinically significant cardiovascular (including postural hypotension), endocrine, renal, ocular, pulmonary or neurological disease.
- History of having received or currently receiving any systemic anti-neoplastic (including radiation) or immune-modulatory treatment (including systemic oral or inhaled corticosteroids,IFN or PEG-IFN) within the 8 weeks prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
- Cohort 4: Concurrent HBV treatments
- History of organ transplantation
- Clinically significant thyroid disease; also, participants with clinically significant elevated TSH concentrations at screening
- Positive results for AMA, ASMA or thyroid peroxidase antibody
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Part I: SAD in Healthy Volunteers
Healthy volunteers will receive single dose of RO7020531 or matching placebo orally on Day 1 of each cohort.
A planned dose-escalation sequence for SAD is 3 milligrams (mg), 10 mg, 20 mg, 40 mg, 60 mg, 100 mg, 140 mg, and 170 mg.
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Placebo matching to RO7020531 will be administered as per schedule specified in the respective arm.
RO7020531 will be administered as per schedule specified in the respective arm.
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Experimental: Part I: MAD in Healthy Volunteers
Healthy volunteers will receive RO7020531 (100 mg, 140 mg, and 170 mg as selected based on safety, pharmacokinetic (PK) and pharmacodynamic (PD) data of SAD cohorts) or matching placebo orally every other day (QOD) from Day 1 through to Day 13.
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Placebo matching to RO7020531 will be administered as per schedule specified in the respective arm.
RO7020531 will be administered as per schedule specified in the respective arm.
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Experimental: Part II: CHB Participants
CHB participants will receive RO7020531 (150 mg and 170 mg as selected based on safety, PK and PD data of MAD cohorts) or matching placebo orally QOD from Day 1 through to Day 41, unless in Cohort 4 in case of once a week (QW) dosing as dose modification.
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Placebo matching to RO7020531 will be administered as per schedule specified in the respective arm.
RO7020531 will be administered as per schedule specified in the respective arm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Part 1: Percentage of SAD Participants With Adverse Events (AEs)
Time Frame: From randomization up to Day 29
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An AE is any untoward medical occurrence in a clinical investigation healthy volunteer (HV)/participant administered a pharmaceutical product, regardless of causal attribution.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition and recurrence of an intermittent medical condition (e.g., headache) not present at baseline.
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From randomization up to Day 29
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Part 1: Percentage of MAD Participants With AEs
Time Frame: From randomization up to Day 41
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An AE is any untoward medical occurrence in a clinical investigation healthy volunteer (HV)/participant administered a pharmaceutical product, regardless of causal attribution.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition and recurrence of an intermittent medical condition (e.g., headache) not present at baseline.
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From randomization up to Day 41
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Part 2: Percentage of Chronic Hepatitis B Participants With AEs
Time Frame: From randomization up to Week 12
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An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition and recurrence of an intermittent medical condition (e.g., headache) not present at baseline.
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From randomization up to Week 12
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Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Time Frame: From randomization up to Day 8
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For all laboratory parameters included, there exists a Roche predefined standard reference range.
Laboratory values falling outside this standard reference range were labeled "H" for high or "L" for low in HV/participant listings of laboratory data.
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From randomization up to Day 8
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Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Time Frame: From randomization up to Day 20
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For all laboratory parameters included, there exists a Roche predefined standard reference range.
Laboratory values falling outside this standard reference range were labeled "H" for high or "L" for low in HV/participant listings of laboratory data.
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From randomization up to Day 20
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Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Time Frame: From randomization up to Week 12
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For all laboratory parameters included, there exists a Roche predefined standard reference range.
Laboratory values falling outside this standard reference range were labeled "H" for high or "L" for low in HV/participant listings of laboratory data.
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From randomization up to Week 12
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Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters
Time Frame: From randomization up to Day 8
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Triplicate 12-lead ECGs were obtained after the participant has been in a supine position for at least 10 minutes.
Clinically significant RO7020531-related changes included confirmation of mean QTc 500 milliseconds (msec) or 60 msec longer than the pre-dose baseline.
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From randomization up to Day 8
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Part 1: Percentage of MAD Participants With Abnormalities in ECG Parameters
Time Frame: From randomization up to Day 20
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Triplicate 12-lead ECGs were obtained after the participants has been in a supine position for at least 10 minutes.
Clinically significant RO7020531-related changes included confirmation of mean QTc 500 msec or 60 msec longer than the pre-dose baseline.
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From randomization up to Day 20
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Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters
Time Frame: From randomization up to Week 12
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Triplicate 12-lead ECGs were obtained after the participant has been in a supine position for at least 10 minutes.
Clinically significant RO7020531-related changes included confirmation of mean QTc 500 msec or 60 msec longer than the pre-dose baseline.
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From randomization up to Week 12
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Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs
Time Frame: From randomization up to Day 8
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Vital signs include blood pressure, pulse rate, respiratory rate and body temperature.
Blood pressure, respiratory rate and pulse rate were obtained after the participant had been in a supine or sitting position for at least 5 minutes.
Blood pressure measurement were performed in triplicate (can be as short as 20 second to 1 minute interval between measurements).
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From randomization up to Day 8
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Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs
Time Frame: From randomization up to Day 20
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Vital signs include blood pressure, pulse rate, respiratory rate and body temperature.
Blood pressure, respiratory rate and pulse rate were obtained after the participant had been in a supine or sitting position for at least 5 minutes.
Blood pressure measurement were performed in triplicate (can be as short as 20 second to 1 minute interval between measurements).
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From randomization up to Day 20
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Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs
Time Frame: From randomization up to Week 12
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Vital signs include blood pressure, pulse rate, respiratory rate and body temperature.
Blood pressure, respiratory rate and pulse rate were obtained after the participant had been in a supine or sitting position for at least 5 minutes.
Blood pressure measurement were performed in triplicate (can be as short as 20 second to 1 minute interval between measurements).
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From randomization up to Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
Time Frame: SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
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SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
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Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
Time Frame: Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
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Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
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Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
Time Frame: SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
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SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
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Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
Time Frame: Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
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Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
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Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
Time Frame: SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
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SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
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Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
Time Frame: Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
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Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
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Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
Time Frame: SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
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SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
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Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
Time Frame: Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
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Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
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Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
Time Frame: SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
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SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13
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Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
Time Frame: Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
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Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41
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Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD
Time Frame: 0 to 24 hrs Postdose on Day 1
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Total amount of the study drug and metabolites recovered in urine was reported.
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0 to 24 hrs Postdose on Day 1
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Part 1:Mean Concentration of Interferon Alpha (IFN-alpha): SAD and MAD
Time Frame: SAD: Predose, 2, 6, 12 and 24 hrs Postdose; MAD: Predose, 2, 6, 12, and 24 hrs Postdose on Day 1; Predose, 2, 6 and 24 hrs Postdose on Days 3, 5, 7, 13 and 20
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Mean concentrations of IFN-alpha for SAD were calculated following single-dose and for MAD it was calculated following multiple doses.
The standard deviation (SD) presented is actually the log transformed geometric standard deviation.
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SAD: Predose, 2, 6, 12 and 24 hrs Postdose; MAD: Predose, 2, 6, 12, and 24 hrs Postdose on Day 1; Predose, 2, 6 and 24 hrs Postdose on Days 3, 5, 7, 13 and 20
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Part 2: Mean Concentration of IFN-alpha
Time Frame: Predose, 6, 8 and 24 hrs Postdose on Day 1; Predose, 4-6, 24 hrs Postdose on Days 3, 7 and 21; Predose, 6, 24 hrs Postdose on Day 41
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Mean concentrations of IFN-alpha for Part 2 were calculated following multiple doses.
The SD presented is actually the log transformed geometric standard deviation.
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Predose, 6, 8 and 24 hrs Postdose on Day 1; Predose, 4-6, 24 hrs Postdose on Days 3, 7 and 21; Predose, 6, 24 hrs Postdose on Day 41
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Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD
Time Frame: SAD: Predose, 2, 6, 12, 24, 48 (only Neopterin) and 96 hrs (only Neopterin) Postdose; MAD: Predose, 2, 6, 12, and 24 hrs Postdose on Day 1; Predose, 2, 6 and 24 hrs Postdose on Days 3, 5, 7, 13 and 20
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Cytokines markers include Chemokine (C-X-C Motif) Ligand 10 (IP-10), Interleukin 6 (IL-6), Interleukin 10 (IL-10), Interleukin 12 p40 (IL-12 p40), Neopterin, Tumor Necrosis Factor-Alpha (TNF-alpha).
The SD presented is actually the log transformed geometric standard deviation.
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SAD: Predose, 2, 6, 12, 24, 48 (only Neopterin) and 96 hrs (only Neopterin) Postdose; MAD: Predose, 2, 6, 12, and 24 hrs Postdose on Day 1; Predose, 2, 6 and 24 hrs Postdose on Days 3, 5, 7, 13 and 20
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Part 2: Mean Fold Change From Baseline in Cytokine Markers
Time Frame: Predose, 6, 8 and 24 hrs Postdose on Day 1; Predose, 4-6, 24 hrs Postdose on Days 3, 7 and 21; Predose, 6, 24 hrs Postdose on Day 41
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Cytokines markers included IP- 10, IL- 6, IL-1 10, IL-12 p40, Neopterin and TNF -alpha.
The SD presented is actually the log transformed geometric standard deviation.
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Predose, 6, 8 and 24 hrs Postdose on Day 1; Predose, 4-6, 24 hrs Postdose on Days 3, 7 and 21; Predose, 6, 24 hrs Postdose on Day 41
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Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD
Time Frame: SAD: Predose, 2, 6, 12 and 24 Postdose; MAD: Predose, 2, 6, 12, and 24 hrs Postdose on Day 1; Predose, 2, 6 and 24 hrs Postdose on Days 3, 5, 7, 13 and 20
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Markers of transcriptional responses includes messenger ribonucleic acid interferon-stimulated gene 15(mRNA ISG15), messenger RNA oligoadenylate synthetase 1 (mRNA OAS1), messenger RNA myxovirus resistance 1 gene (mRNA MX-1), messenger RNA Toll-like receptor (mRNA TLR7).
The SD presented is actually the log transformed geometric standard deviation.
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SAD: Predose, 2, 6, 12 and 24 Postdose; MAD: Predose, 2, 6, 12, and 24 hrs Postdose on Day 1; Predose, 2, 6 and 24 hrs Postdose on Days 3, 5, 7, 13 and 20
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Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses
Time Frame: Predose, 6, 8, 24 hrs postdose on Day 1; Predose, 4-6, 24 hrs postdose on Days 3, 7, 21; Predose, 6, 24 hrs postdose on Day 41
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Transcriptional markers include mRNA ISG15, mRNA OAS1, mRNA MX-1, mRNA TLR7.
The SD presented is actually the log transformed geometric standard deviation.
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Predose, 6, 8, 24 hrs postdose on Day 1; Predose, 4-6, 24 hrs postdose on Days 3, 7, 21; Predose, 6, 24 hrs postdose on Day 41
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Effect of RO7020531 Dosing on ECG Parameters (PR [PQ], QRS, QT, QTcF in Miliseconds [ms]) Using Exposure-response Analysis: SAD and MAD
Time Frame: SAD: Predose, 0.5, 1, 2, 4, 6, 12, 24 and 48 hrs Post dose on Day 1; MAD: Predose, 0.5, 1,2,4 and 12 hrs Postdose on Day 1 and 13; Predose, 2 and 6 hrs Postdose on Day 3, Predose, 6 and 24 hrs Postdose on Day , 7, 9, and 11
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SAD: Predose, 0.5, 1, 2, 4, 6, 12, 24 and 48 hrs Post dose on Day 1; MAD: Predose, 0.5, 1,2,4 and 12 hrs Postdose on Day 1 and 13; Predose, 2 and 6 hrs Postdose on Day 3, Predose, 6 and 24 hrs Postdose on Day , 7, 9, and 11
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Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Time Frame: Pre-dose and 2-4 hours post-dose on Day 1, Day 21 and Day 41
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Adefovir was not administered to any participants in the study.
Hence, no data could be collected for plasma concentration of adefovir.
As participants in each cohort received different NUCs the data for Cohorts 1, 2 and 3 have been reported separately.
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Pre-dose and 2-4 hours post-dose on Day 1, Day 21 and Day 41
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 12, 2016
Primary Completion (Actual)
June 15, 2021
Study Completion (Actual)
June 15, 2021
Study Registration Dates
First Submitted
November 3, 2016
First Submitted That Met QC Criteria
November 3, 2016
First Posted (Estimated)
November 6, 2016
Study Record Updates
Last Update Posted (Actual)
February 8, 2024
Last Update Submitted That Met QC Criteria
February 6, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Disease Attributes
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Chronic Disease
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
Other Study ID Numbers
- NP39305
- 2016-003723-38 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatitis B, Chronic
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The Affiliated Nanjing Drum Tower Hospital of Nanjing...Gilead SciencesNot yet recruiting
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Tongji HospitalGilead SciencesRecruiting
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Jiangsu HengRui Medicine Co., Ltd.Unknown
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Changhai HospitalCompleted
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Zhongshan Hospital Xiamen UniversityUnknownHealthy | Chronic Hepatitis B InfectionChina
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Tongji HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownChronic Hepatitis b
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Brii Biosciences LimitedVir Biotechnology, Inc.Active, not recruitingChronic Hepatitis B Virus InfectionSingapore, Thailand, Australia, China, Korea, Republic of
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Nanfang Hospital of Southern Medical UniversityRecruiting
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IlDong Pharmaceutical Co LtdRecruitingChronic Hepatitis bKorea, Republic of
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Antios Therapeutics, IncTerminatedChronic Hepatitis bUnited States
Clinical Trials on Placebo
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SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
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National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
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AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
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Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
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GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
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ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
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Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
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GlaxoSmithKlineCompletedInfections, BacterialUnited States
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West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States