Clinical trials: sponsored by Hoffmann-La Roche
Healthy Volunteer
A Single-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Gantenerumab Following Subcutaneous (SC) Administration in Healthy Volunteers
This two-part study is designed to assess the safety, tolerability, and PK of gantenerumab in healthy volunteers. Part I (dose escalation) will randomly assign participants to receive a single blinded SC dose of gantenerumab or…
- Trial name
- NCT02711423
- Testing
- Gantenerumab
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Duchenne Muscular Dystrophy, Burden, Dependency
Your Voice; Impact of Duchenne Muscular Dystrophy (DMD) on the Lives of Families
The purpose of this study is to improve the understanding of the treatment goals that a person with Duchenne Muscular Dystrophy (DMD) or the caregiver may be most interested in, based on the severity of the person's disease.
- Conditions
- Duchenne Muscular Dystrophy, Burden, Dependency, Disability Physical, Disease Management
- Trial name
- NCT03680365
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Jett Foundation, Inc.
Multiple Sclerosis
Monitoring of Multiple Sclerosis (MS) Participants With the Use of Digital Technology (Smartphones and Smartwatches) - A Feasibility Study
This prospective pilot study will assess the feasibility of remote participant monitoring using digital technology in participants with MS and healthy controls.
- Trial name
- NCT02952911
- Testing
- Smartphone and Smartwatch
- Where
- 2 sites in United States, Spain
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Alzheimer's Disease, Healthy Volunteer
Evaluation of [11C]RO6924963, [11C]RO6931643, and [18F]RO6958948 as Tracers for Positron Emission Tomography (PET) Imaging of Tau in Healthy and Alzheimer's Disease (AD) Participants
This study is designed to obtain basic information on three PET imaging tracers developed to detect tau pathology in the brain. In this study, healthy control participants and participants with AD will be studied.
- Trial name
- NCT02187627
- Testing
- [11C]RO6924963, [11C]RO6931643, [18F]RO6958948
- Where
- 2 sites in United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Participants
Relative Bioavailability of Gantenerumab Produced by G4 Process Versus G3 Process Following Subcutaneous (SC) Injection in Healthy Participants
The purpose of this study is to assess the relative bioavailability of the high concentration liquid formulation (HCLF) of gantenerumab produced with the G4 process in comparison to the same HCLF of gantenerumab produced with the…
- Trial name
- NCT03236844
- Testing
- Gantenerumab
- Where
- 3 sites in United States
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Participants
Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers
The purpose of this study is to determine the excretion kinetics and mass balance of fenebrutinib in healthy male subjects.
- Trial name
- NCT03596632
- Testing
- Fenebrutinib
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Spinal Muscular Atrophy
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Risdiplam (RO7034067) Given by Mouth in Healthy Volunteers
The objective of this study is to assess the safety and tolerability of Risdiplam (RO7034067) in healthy people. The study will assess what the body does to Risdiplam (RO7034067) and what Risdiplam (RO7034067) does to the body.
- Trial name
- NCT02633709
- Testing
- Itraconazole, Risdiplam
- Where
- Netherlands
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy
A Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-Labeled Risdiplam (RO7034067) in Healthy Male Participants
This is an open-label, non-randomized study investigating the excretion balance, PK and metabolism of a single oral dose of [14C]-labeled Risdiplam (RO7034067) in healthy male participants.
- Trial name
- NCT03036501
- Testing
- [^14C]-Risdiplam
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Risdiplam (RO7034067) in Healthy Japanese Participants
This is a randomized, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single oral doses of Risdiplam in healthy Japanese participants.
- Trial name
- NCT03040635
- Testing
- Risdiplam
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatic Impairment
Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib
This is a multicenter, non-randomized, single-dose, open-label study conducted in male and surgically sterile or post-menopausal female participants with stable chronic hepatic impairment and in healthy participants matched by…
- Trial name
- NCT02621047
- Testing
- Alectinib
- Where
- 2 sites in Czechia, Slovakia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteer
A Study of RO6870868 in Healthy Volunteers
This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics of RO6870868 in healthy volunteers.
- Trial name
- NCT01911611
- Testing
- RO6870868
- Where
- Netherlands
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Early Breast Cancer
A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC)
This study involves a two-part design. Part 1 is designed to determine the optimal dose of subcutaneous (SC) Perjeta, injected alone or mixed with Herceptin, that results in comparable exposure to intravenous (IV) Perjeta.
- Trial name
- NCT02738970
- Testing
- Trastuzumab, Pertuzumab
- Where
- 2 sites in New Zealand
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Gram-negative Bacterial Infections
A Study to Investigate the Intrapulmonary Lung Penetration of Nacubactam in Healthy Participants
The purpose of this study is to characterize the intrapulmonary penetration of nacubactam in healthy volunteers. Nacubactam is a novel non-beta-lactam beta-lactamase inhibitor being developed as a combination therapy with the…
- Trial name
- NCT03182504
- Testing
- nacubactam, meropenem
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Solid Tumors, Advanced Solid Tumors
A Two Part Study of RO6870810. Dose-Escalation Study in Participants With Advanced Solid Tumors and Expansion Study in Participants With Selected Malignancies
This is a Phase 1, non-randomized, dose-escalating, open label, multi-center study to be conducted in two parts (Part A and Part B).
- Trial name
- NCT01987362
- Testing
- RO6870810
- Where
- 4 sites in United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Renal Impairment
A Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics (PK) of RO7079901
This is a multi-center, non-randomized, open-label, two-part study to investigate the effect of renal function and hemodialysis on PK of RO7079901.
- Trial name
- NCT02975388
- Testing
- RO7079901
- Where
- 5 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteer
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of RO6889450 in Healthy Volunteers
This randomized, single center, adaptive single ascending dose (Part 1) and multiple ascending dose (Part 2) study is designed to assess the safety, tolerability, pharmacokinetic, and pharmacodynamics following an oral…
- Trial name
- NCT02699372
- Testing
- RO6889450
- Where
- Netherlands
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
A Study to Evaluate the Effect of a Potent Cytochrome P450 (CYP) 3A Inhibitor on Ipatasertib
This study will be a single center, open-label, 2-period, fixed-sequence, Phase 1 drug-drug interaction study in healthy subjects.
- Trial name
- NCT03222310
- Testing
- Ipatasertib, Itraconazole
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteer
A Study Exmining the Effect of Multiple Doses of Bitopertin on the Single Dose Pharmacokinetics of Midazolam in Healthy Volunteers.
This will be a single-center, open-label, inpatient/outpatient, fixed-sequence study examining the effect of multiple doses of bitopertin on single doses of Midazolam in healthy volunteers.
- Trial name
- NCT02019290
- Testing
- Midazolam, bitopertin
- Volunteers
- healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Adults
Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects
The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of single and multiple doses of BMS-986089 in healthy adult subjects.
- Trial name
- NCT02145234
- Testing
- BMS-986089
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteer, Type 2 Diabetes
A Study to Investigate in Healthy Volunteers (Part 1) and in Patients With Type 2 Diabetes Mellitus (Part 2) the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of RO6799477
This study is designed to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO6799477 following once daily oral administration for 2 weeks in healthy volunteers (Part 1) and in Type 2 diabetes…
- Trial name
- NCT02164266
- Testing
- RO6799477
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche