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RO7017773 Phase I

Phase 1

Healthy Volunteers | Small molecule | Other |Roche Holding AG|Last Updated: May 28, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

RO7017773 Phase I · 1 trial · 1 indication

Phase 1 1
NCT03847987A 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 ParticipantsHealthy Volunteers
COMPLETED24 Analytics
PHASE1COMPLETED
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
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax) of RO7017773 (Part 1)
Day 1 to Day 5
Cmax of RO7017773 (Part 2)
Day 1 to Day 5
Taste Assessment, as Measured by Taste Questionnaire (Part 2)
Day 1

Taste was assessed using a questionnaire that asking participants to rate the overall taste of study drug dispersed in various vehicles on a scale from 1-5, with 1=no taste, and 5=very intense taste.

Secondary Endpoints

Taste Assessment, as Measured by Taste Questionnaire (Part 1)
Day 1
Percentage of Participants With Adverse Events (AEs)
Baseline through end of study (approximately 6 weeks)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1EXPERIMENTALParticipants will receive 4 single oral doses of RO7017773 under either fed or fasted conditions, one of which will be a taste assessment. There will be a 7-10 day washout period between doses.
Part 2EXPERIMENTALParticipants will receive 2 single oral doses of RO7017773, either sweetened/flavored, or unflavored and dispersed in juice. There will be a 7-10 day washout period between doses.

Interventions

NameTypeDescription
RO7017773 Phase I CapsuleDRUGParticipants will receive 1 single oral dose of RO7017773 Phase I Capsule.
RO7017773 Phase II Tablet UnflavoredDRUGParticipants will receive 3 single oral doses of unflavored RO7017773 Phase II tablet during Part 1, and 1 single oral dose of unflavored RO7017773 Phase II tablet during Part 2.
RO7017773 Phase II Tablet Sweetened/FlavoredDRUGParticipants will receive 1 single oral dose of sweetened/flavored RO7017773 Phase II tablet during Part 2.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria * Non-smoker for at least six months * Healthy, as judged by the Investigator * Women of non-childbearing potential (WONCBP) who are not pregnant or lactating * Men must be willing to remain abstinent or agree to use contraceptive measures with partners who are women of childbear...

Countries:United States
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Frequently asked questions about RO7017773 Phase I

What is RO7017773 Phase I used for?

RO7017773 Phase I 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 assessed the relative bioavailability of tablet versus capsule formulations, the effect of food, and taste assessment of the tablet formulation in healthy participants.

Who makes RO7017773 Phase I?

RO7017773 Phase I is being developed by Roche Holding AG, traded on the OTC market under the ticker RHHBY. The company conducted a Phase 1 clinical trial of this investigational small molecule in healthy volunteers in the United States.

What phase is RO7017773 Phase I in?

RO7017773 Phase I is in Phase 1 clinical development. It is an investigational drug, not approved by regulatory authorities. One Phase 1 trial has been completed, with no active trials currently ongoing for this asset.

What clinical trials is RO7017773 Phase I in?

RO7017773 Phase I has one completed clinical trial, NCT03847987. This was a two-part study in healthy participants to assess the relative bioavailability of tablet versus capsule formulations, the effect of food, and taste assessment of the tablet formulation. The trial enrolled 24 participants in the United States.

Is RO7017773 Phase I the same as RO7017773?

RO7017773 Phase I refers to the same investigational drug, RO7017773, which is currently in Phase 1 clinical development. The name includes the phase to distinguish the development stage, but the compound is identical. It is being studied in healthy volunteers for formulation assessment.