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RO5093151

Phase 2

Hypertension, Glaucoma, Open-Angle | Small molecule | Cardiovascular |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

RO5093151 · 3 trials · 3 indications

Phase 2 1Phase 1 2
NCT01493271A Study of RO5093151 in Patients With Ocular Hypertension Or Open Angle GlaucomaHypertension, Glaucoma, Open-Angle
COMPLETED31 Analytics
PHASE2COMPLETED
A Study of RO5093151 in Patients With Ocular Hypertension Or Open Angle Glaucoma
Hypertension, Glaucoma, Open-AngleUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment
Day 7
Part 1: Effect of multiple doses of ketoconazole on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)
Pre-dose and up to 72 hours post-dose
Part 2: Effect of multiple doses of rifampicin on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)
Pre-dose and up to 72 hours post-dose
Part 3: Effect of multiple doses of ritonavir-boosted atazanavir on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)
Pre-dose and up to 72 hours post-dose
Change of liver fat content measured by magnetic resonance spectroscopy (MRS)
Week 12

Secondary Endpoints

Change in mean daily intraocular pressure (IOP)
Up to 28 days
Change in mean intraocular pressure (IOP) at each assessment time-points
Up to 28 days
Change in intraocular pressure (IOP) during a placebo lead-in phase
7 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
RO5093151EXPERIMENTAL -
1 Ketoconazole DDIEXPERIMENTAL -
2 Rifampicin DDIEXPERIMENTAL -
3 ATZ/r DDIEXPERIMENTAL -
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PlaceboDRUGPlacebo to RO5093151
RO5093151DRUGoral doses twice daily for up to 28 days
atazanavirDRUGMultiple oral doses
ketoconazoleDRUGMultiple oral doses
rifampicinDRUGMultiple oral doses
ritonavirDRUGMultiple oral doses
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Eligibility Criteria

Age Range21 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Adult patients, at least 21 years of age, inclusive * Diagnosis of ocular hypertension or primary open angle glaucoma in at least one eye * Able to participate and willing to give informed consent Exclusion Criteria: * Presence of extreme narrow angle with complete or partia...

Countries:United StatesBulgariaCzechiaHungaryAustriaGermany
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Frequently asked questions about RO5093151

What is RO5093151 used for?

RO5093151 is an investigational small molecule being studied for non-alcoholic fatty liver disease (NAFLD), ocular hypertension, and open-angle glaucoma. It has also been evaluated in healthy volunteers for drug-drug interaction studies. The compound is in clinical development by Roche Holding AG.

Who makes RO5093151?

RO5093151 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored clinical trials of the drug in patients with non-alcoholic fatty liver disease, ocular hypertension, and open-angle glaucoma, as well as in healthy volunteers.

What phase is RO5093151 in?

RO5093151 has completed Phase 1 and Phase 2 clinical trials. A Phase 1 study in non-alcoholic fatty liver disease and a Phase 2 study in ocular hypertension or open-angle glaucoma have both been completed. The drug remains investigational and is not approved.

What clinical trials has RO5093151 been in?

RO5093151 has been studied in three completed trials. NCT01277094 was a Phase 1 study in 82 patients with non-alcoholic fatty liver disease in Austria and Germany. NCT01493271 was a Phase 2 study in 31 patients with ocular hypertension or open-angle glaucoma. NCT01591850 was a Phase 1 drug-drug interaction study in 51 healthy volunteers.

Is RO5093151 the same as any other drug?

RO5093151 is the sole name reported for this investigational compound. No alternative names have been associated with it in the clinical trial records. It is a small molecule developed by Roche Holding AG for metabolic and ophthalmologic conditions.