Clinical trials: sponsored by Hoffmann-La Roche
Chronic Hepatitis B
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
This is a first in human (FIH), multi-center, dose-finding, and dose-escalation Phase I clinical study of RO7565020 to investigate the safety and tolerability and to characterize the pharmacokinetics and pharmacodynamics…
- Trial name
- NCT05763576
- Testing
- RO7565020, Nucleos(t)ide analogue (NUC) treatment
- Where
- 9 sites in United States, Hong Kong and 5 more
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Chronic
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
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…
- Trial name
- NCT02952924
- Testing
- Midazolam, RO7049389
- Where
- 21 sites in Australia, Bulgaria and 6 more
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Male Subjects
A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System
This is a randomized, open-label, 2-arm, parallel-group, single-dose, multi-center study in healthy male subjects to investigate the comparability of the pharmacokinetics of the fixed-dose combination of pertuzumab and…
- Trial name
- NCT05275010
- Testing
- Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (PH FDC SC), Handheld Syringe with Hypodermic Needle, On-Body Delivery System
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatic Insufficiency
A Study to Investigate the Effect of Impaired Hepatic Function on the Pharmacokinetics of Entrectinib in Volunteers With Different Levels of Hepatic Function
This is a non-randomized, open-label, one treatment, four group, parallel group study to investigate the effect of impaired hepatic function on the pharmacokinetics of entrectinib in participants with different levels of hepatic…
- Trial name
- NCT04226833
- Testing
- entrectinib
- Where
- 3 sites in Czechia, Hungary and 1 more
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
Mass Balance and Absolute Bioavailability Study of RO7049389 in Healthy Volunteers
The objective of this study is to characterize the mass balance, absolute bioavailability, route and rates of elimination of RO7049839.
- Trial name
- NCT04729309
- Testing
- [12C] RO7049389, [13C] RO7049389, [14C] RO7049389
- Where
- United Kingdom
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Autistic Disorder, Autism Spectrum Disorder
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of RO6953958 in Healthy Participants
This study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses (SAD (Part 1) and MAD (Part 2)) and food effect (FE) of RO6953958 following oral…
- Conditions
- Autistic Disorder, Autism Spectrum Disorder, Child Development Disorders, Pervasive, Mental Disorders
- Trial name
- NCT04475848
- Testing
- RO6953958, Midazolam
- Where
- United Kingdom
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Chronic
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
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…
- Trial name
- NCT02956850
- Testing
- RO7020531
- Where
- 18 sites in Bulgaria, Hong Kong and 6 more
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteer
A Cross-over Study Examining the Bioequivalence of 3 Test Formulations to a Reference Formulation of Alectinib (RO5424802) in Healthy Volunteers
This 2-part, single center, open-label, randomized, single-dose, 4-sequence, 4-period cross-over study will compare the bioequivalence of three test RO5424802 capsule formulations with the reference capsule formulation in healthy…
- Trial name
- NCT02074553
- Testing
- Ro542-4802/F03 (Reference), Ro542-4802/F07 (Test), Ro542-4802/F08 (Test)
- Where
- United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Autism Spectrum Disorder
A Study to Evaluate Scales for Repetitive and Restricted Behaviors in Children, Adolescents, and Adults With Autism Spectrum Disorder (ASD)
This is a non-drug study seeking to characterize different scales to measure repetitive and restrictive behaviors in different ASD sub-populations over time. This study will also explore the use of digital biomarkers.
- Trial name
- NCT03611075
- Testing
- No Intervention
- Where
- 18 sites in United States, Canada and 1 more
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Alzheimers Disease
A Single Ascending Dose Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Intravenously Administered RO7126209 in Healthy Participants
Study BP41192 is a randomized, adaptive, placebo-controlled parallel group study to investigate the safety, tolerability, immunogenicity and pharmacokinetics of single-ascending intravenous (IV) doses of RO7126209 in healthy…
- Trial name
- NCT04023994
- Testing
- RO7126209
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatitis B Virus Infection
A Study of RO7239958 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection
This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses in healthy volunteers (HV) and participants diagnosed with chronic hepatitis B…
- Trial name
- NCT03762681
- Testing
- RO7239958
- Where
- 14 sites in Bulgaria, Hong Kong and 5 more
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Autism Spectrum Disorder
A Study to Investigate the Effect of Esomeprazole and the Effect of Food on the Pharmacokinetics of Balovaptan in Healthy Volunteers
This study will investigate the effect of food and the effect of esomeprazole on the pharmacokinetics (PK) of a single dose of balovaptan in healthy volunteers.
- Trial name
- NCT04156646
- Testing
- Balovaptan, Esomeprazole
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Muscular Atrophy, Spinal
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics and Safety and Tolerability of a Single Oral Dose of Risdiplam Compared to Matched Healthy Participants With Normal Hepatic Function
This is a multi-center, open-label, non-randomized, parallel-group, 2-part study to evaluate the effect of hepatic impairment on the PK and safety and tolerability of a single oral dose of risdiplam compared to matched healthy…
- Trial name
- NCT03920865
- Testing
- Risdiplam
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of RO7062931in Healthy Volunteers and Subjects With Chronic Hepatitis B
This randomized study will be conducted in two parts to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of subcutaneous administration of RO7062931.
- Trial name
- NCT03038113
- Testing
- RO7062931, Immune Modulator
- Where
- 19 sites in Australia, Hong Kong and 5 more
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Spinal Muscular Atrophy
A Drug-drug Interaction Study With Risdiplam Multiple Dose and Midazolam in Healthy Participants
This will be a Phase I, 2-part, open-label, non-randomized study to investigate the safety, tolerability, and pharmacokinetics (PK) of a multiple-dosing regimen of risdiplam (Part 1) and the effect of risdiplam on the PK of…
- Trial name
- NCT03988907
- Testing
- Risdiplam, Midazolam
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteer
Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants
This study will evaluate the pharmacokinetics, safety and tolerability of a single oral dose of baloxavir marboxil (40 mg or 80 mg) in healthy Chinese participants.
- Trial name
- NCT03959332
- Testing
- Baloxavir Marboxil
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Participants
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RO7062931 in Healthy Chinese Volunteers.
This randomized study will evaluate the safety, tolerability and pharmacokinetics of single ascending subcutaneously administered doses of RO7062931 in healthy volunteers.
- Trial name
- NCT03505190
- Testing
- RO7062931
- Where
- 2 sites in Hong Kong
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects
This was a single-center, multiple-dose, randomized, double-blind, placebo-controlled, positive-controlled, twelve sequence, 3-period cross-over study to investigate the effect of balovaptan on the QTc interval in healthy…
- Trial name
- NCT03808298
- Testing
- Balovaptan therapeutic dose Treatment A, Balovaptan supra-therapeutic dose Treatment B, Active control [moxifloxacin] on Day 2 Treatment C
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Participants
A Study to Assess the Safety and Tolerability of Single and Multiple Ascending Doses of Oral RO7020531 in Chinese Healthy Participants.
To evaluate the safety and tolerability of single and multiple ascending doses of oral RO7020531 in Chinese healthy participants.
- Trial name
- NCT03530917
- Testing
- RO7020531
- Where
- Hong Kong
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
A 2 Part Study to Assess the Relative Bioavailability of Tablet Formulation Compared to Capsule Formulation and the Effect of Food and Taste Assessment on the Tablet Formulation in Healthy Participants
This is a two-part, open-label, healthy volunteer study. Part I will investigate the relative bioavailability of capsule and tablet formulations of RO7017773.
- Trial name
- NCT03847987
- Testing
- RO7017773 Phase I Capsule, RO7017773 Phase II Tablet Unflavored, RO7017773 Phase II Tablet Sweetened/Flavored
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche