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

PHASE1CompletedINTERVENTIONAL
Enrollment

192

Participants

Timeline

Start Date

December 14, 2016

Primary Completion Date

March 16, 2022

Study Completion Date

March 16, 2022

Conditions
Hepatitis B, Chronic
Interventions
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.

Trial Locations (21)

112

Taipei Veterans General Hospital, Taipei

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

1010

Auckland Clinical Studies Limited, Grafton

1407

Acibadem City Clinic Tokuda Hospital Ead, Sofia

3050

Royal Melbourne Hospital, Parkville

4029

Royal Brisbane and Women's Hospital, Herston

10330

King Chulalongkorn Memorial Hospital, Bangkok

10700

Siriraj Hospital, Bangkok

40705

Taichung Veterans Gen Hosp, Taichung

50200

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai

70457

National Cheng Kung University Hospital, Tainan City

119228

National University Health System, Singapore

169608

Singapore General Hospital, Singapore

200025

Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital), Shanghai

200040

Huashan Hospital Affiliated to Fudan University, Shanghai

510515

Nanfang Hospital, Southern Medical University, Guangzhou

Unknown

The University of Hong Kong; Queen Mary Hospital, Hong Kong

Prince of Wales Hospital, Shatin, New Territories

Middlemore Hospital, Auckland

Chang Gung Memorial Hospital - Kaohsiung Branch, Kaohsiung City

Chang Gung Memorial Hospital - Linkou Branch, Taipei

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

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 | Biotech Hunter | Biotech Hunter