Recent Updates
Recently added Catalysts

RO6836191

Phase 1

Atherosclerosis | Small molecule | Cardiovascular |Roche Holding AG|Last Updated: Nov 4, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment88

FDA Designations

No designations recorded

Clinical trial landscape

RO6836191 · 1 trial · 1 indication

Phase 1 1
NCT01995383A Single Ascending Dose Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of RO6836191 in Healthy Male Volunteers.Atherosclerosis
COMPLETED88 Analytics
PHASE1COMPLETED
A Single Ascending Dose Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of RO6836191 in Healthy Male Volunteers.
AtherosclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 2: Area under the concentration-time curve (AUC)
Up to Day 35
Part 2: Plasma aldosterone levels
Up to 2 days after drug administration
Part 2: Urine aldosterone levels
Up to 3 days after drug administration
Part 1: Plasma aldosterone levels
Up to Day 5
Part 1: Urine aldosterone levels
Up to Day 3
Part 2: Incidence of AEs
Up to 12 weeks
Parts 1: Incidence of adverse events (AE)
Until Day 21

Secondary Endpoints

Part 2: Volume of distribution after intravenous administration
Days 28-37
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Placebo (PL)PLACEBO_COMPARATOR -
Part 1: Single Ascending Doses (SAD) of RO6836191EXPERIMENTAL -
Part 2: PL: Low-salt (LS) followed by normal-salt (NS) dietPLACEBO_COMPARATOR -
Part 2: PL: NS followed by LS dietPLACEBO_COMPARATOR -
Part 2: RO6836191: LS followed by NS dietEXPERIMENTAL -
Part 2: RO6836191: NS followed by LS dietEXPERIMENTAL -

Interventions

NameTypeDescription
LS followed by NS diet conditionOTHERLS diet period followed by NS diet period
NS followed by LS diet conditionOTHERNS diet period followed by LS diet period
PlaceboDRUGSingle oral administrations
RO6836191DRUGOrally administered, single ascending doses
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male volunteers, aged 18 to 45 years old. * No active or chronic disease following a detailed medical and surgical history and complete physical examination. * A BMI between 18 to 30 kg/m2 inclusive. * Use of a highly effective form of birth control for the duration of...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about RO6836191

What is RO6836191 used for?

RO6836191 is an investigational small molecule being developed by Roche Holding AG for the treatment of atherosclerosis, a cardiovascular condition characterized by the buildup of plaque in the arteries. It is currently in Phase 1 clinical development.

Who makes RO6836191?

RO6836191 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is an investigational small molecule intended for the treatment of atherosclerosis and is currently in Phase 1 clinical trials.

What phase is RO6836191 in?

RO6836191 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for its safety, pharmacokinetics, and pharmacodynamics in healthy volunteers.

What clinical trials is RO6836191 in?

RO6836191 has one completed clinical trial, identified as NCT01995383. This was a Phase 1, single ascending dose study that investigated the safety, pharmacokinetics, and pharmacodynamics of RO6836191 in healthy male volunteers. The trial enrolled 88 participants and was conducted in the United States.

Is RO6836191 the same as any other drug?

RO6836191 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is being developed by Roche Holding AG for the treatment of atherosclerosis.