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RO5271983- MAD

Phase 1

Healthy Volunteer | Small molecule | Other |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment82

FDA Designations

No designations recorded

Clinical trial landscape

RO5271983- MAD · 1 trial · 1 indication

Phase 1 1
NCT01209221A Single Ascending And Multiple Ascending Dose Study of RO5271983 in Healthy VolunteersHealthy Volunteer
COMPLETED82 Analytics
PHASE1COMPLETED
A Single Ascending And Multiple Ascending Dose Study of RO5271983 in Healthy Volunteers
Healthy Volunteer
NCT0120922182
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Study Endpoints

Primary Endpoints

Single ascending dose (SAD): Pharmacokinetics (plasma concentration) of RO5271983
up to 240 hours
Single ascending dose (SAD): Safety (incidence of adverse events)
14 weeks
Single ascending dose (SAD): Tolerability (e.g. vital signs)
14 weeks
Multiple ascending doses (MAD): Pharmacokinetics (plasma concentration) of RO5271983
17 days
Multiple ascending doses (MAD): Safety (incidence of adverse events)
8 weeks
Multiple ascending doses (MAD): Tolerability (e.g. vital signs)
8 weeks

Secondary Endpoints

Effect of food on pharmacokinetics of RO5271983
up to 240 hours
Single ascending dose (SAD): Pharmacodynamics (blood analysis) of RO5271983
72 hours
Multiple ascending doses (MAD): Pharmacodynamics (blood analysis) of RO5271983
14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3PLACEBO_COMPARATOR -
4PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Placebo - MADDRUGOnce or twice daily doses of matching placebo to RO5271983 for 14 days
Placebo - SADDRUGSingle dose of matching placebo to RO5271983 for up to 3 periods
RO5271983 - MADDRUGOnce or twice daily doses of RO5271983 for 14 days
RO5271983 - SADDRUGSingle dose of RO5271983 at each period (for up to 3 periods)
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy volunteers, 18-65 years of age * Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive * In the SAD, females subjects must be surgically sterile or post-menopausal for the past year; in the MAD females may be of child-bearing potential but must use 2 methods of high...

Countries:New Zealand
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Frequently asked questions about RO5271983- MAD

What is RO5271983-MAD used for?

RO5271983-MAD is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in early clinical development. The completed Phase 1 trial evaluated the drug in healthy participants to assess its safety and tolerability.

Who makes RO5271983-MAD?

RO5271983-MAD is being developed by Roche Holding AG, traded on the OTC market under the ticker RHHBY. The company sponsored a Phase 1 clinical trial of the drug in healthy volunteers.

What phase is RO5271983-MAD in?

RO5271983-MAD is in Phase 1 clinical development. The single completed trial was a Phase 1 study in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is RO5271983-MAD in?

RO5271983-MAD has one completed clinical trial, NCT01209221, titled "A Single Ascending And Multiple Ascending Dose Study of RO5271983 in Healthy Volunteers." This Phase 1 study enrolled 82 participants in New Zealand and was placebo-controlled.

Is RO5271983-MAD FDA approved?

RO5271983-MAD is not FDA approved. It is an investigational drug that has only completed a Phase 1 trial in healthy volunteers. No efficacy or approval data has been established for this compound.