NCT02952924

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7049389 in Healthy Volunteers and Chronic Hepatitis B Virus (HBV) Infected Participants

A Safety, Tolerability, Pharmacokinetics and Efficacy Study of ro7049389 in: (1) Single- (With or Without Food) and Multiple- (With Midazolam) Ascending Doses in Healthy Volunteers; (2) Patients Chronically Infected With Hepatitis b Virus (3) Patients With Chronic Hepatitis B.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study is a multicenter, three-part study. Parts 1 and 2 are randomized, investigator- and participant-blinded, placebo-control, single-ascending dose (SAD) and multiple-ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7049389 following oral administration in healthy volunteers and chronic HBV infected participants. Part 3 is a non-randomized, non-controlled, open-label part to assess the efficacy and safety of RO7049389 when administered in combination with standard-of-care therapies for up to 48 weeks in nucleos(t)ide (NUC)-suppressed and treatment-naive chronic hepatitis B (CHB) participants.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	Midazolam	Single dose of 100 mcg midazolam solution will be administered orally, before (Day -1) and after (Day 14) the treatment with RO7049389 or matching placebo
OTHER	Placebo	Placebo matching to RO7049389 will be administered as per schedule described in individual arm.
DRUG	RO7049389	RO7049389 will be administered as per schedule described in individual arm.

Timeline

• Start date: 2016-12-14
• Primary completion: 2022-03-16
• Completion: 2022-03-16
• First posted: 2016-11-02
• Last updated: 2024-10-31
• Results posted: 2024-10-31

Locations

21 sites across 8 countries: Australia, Bulgaria, China, Hong Kong, New Zealand, Singapore, Taiwan, Thailand