A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7020322 Following Oral Administration in Healthy Participants and Chronic Hepatitis B Patients
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ClinicalTrials.gov Identifier: NCT02604355 |
Recruitment Status
:
Terminated
(Molecule Development was Terminated)
First Posted
: November 13, 2015
Last Update Posted
: May 25, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis B, Chronic | Other: Matching Placebo Drug: RO7020322 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 49 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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 |
Actual Study Start Date : | November 28, 2015 |
Actual Primary Completion Date : | May 9, 2016 |
Actual Study Completion Date : | May 9, 2016 |
Arm | Intervention/treatment |
---|---|
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.
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- Number of participants with adverse events [ Time Frame: Up to 8 weeks ]
- Intensity of adverse events [ Time Frame: Up to 8 weeks ]
- Number of participants with clinically significant laboratory abnormalities [ Time Frame: Up to 8 weeks ]
- Number of participants with clinically significant electrocardiogram (ECG) abnormalities [ Time Frame: Up to 8 weeks ]
- Number of participants with clinically significant vital signs abnormalities [ Time Frame: Up to 8 weeks ]
- Maximum observed plasma concentration (Cmax) of RO7020322 [ Time Frame: Up to 18 days ]
- Time from dosing to Cmax (Tmax) of RO7020322 [ Time Frame: Up to 18 days ]
- Trough plasma concentrations (Ctrough) of RO7020322 [ Time Frame: Up to 18 days ]
- 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 ]
- 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 ]
- Apparent clearance (CL/F) of RO7020322 [ Time Frame: Up to 18 days ]
- Apparent volume (V/F) of RO7020322 [ Time Frame: Up to 18 days ]
- Apparent terminal phase half-life (t1/2) of RO7020322 [ Time Frame: Up to 18 days ]
- Area under the plasma concentration-time curve (AUC0-t,ss) of RO7020322 at steady state [ Time Frame: Up to 18 days ]
- Area under the plasma concentration-time curve (AUC0-t) of RO7020322 on Day 1 [ Time Frame: Up to 18 days ]
- Plasma concentration of hepatitis B surface antigen (HBsAg) [ Time Frame: Up to 8 weeks ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02604355
Hong Kong | |
Queen Mary Hospital | |
Hong Kong, Hong Kong | |
New Zealand | |
Auckland Clinical Studies Limited | |
Grafton, New Zealand, 1010 | |
Tauranga Hospital | |
Tauranga, New Zealand, 3143 | |
Taiwan | |
Kaohsiung Medical University Chung-Ho Memorial Hospital | |
Kaohsiung, Taiwan, 807 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT02604355 History of Changes |
Other Study ID Numbers: |
BP29948 |
First Posted: | November 13, 2015 Key Record Dates |
Last Update Posted: | May 25, 2017 |
Last Verified: | May 2017 |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis B Hepatitis B, Chronic Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |