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RO7017773 Phase I

Phase 1

Undisclosed | Small molecule | Other |Roche Holding AG|Trials Updated: May 28, 2020

RO7017773 Phase I target and mechanism

ModalitySmall molecule

Also known as RO7017773 Phase I Capsule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

RO7017773 Phase I clinical trials

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?

RO7017773 Phase I is an investigational small molecule developed by Roche Holding AG. It has been studied in a Phase 1 clinical trial in healthy volunteers, not in patients with a disclosed disease. The program is in early clinical development, and no approved indication has been announced.

Who makes RO7017773 Phase I?

RO7017773 Phase I is made by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the developer of the compound and sponsored the Phase 1 study that evaluated it in healthy participants.

What phase is RO7017773 Phase I in?

RO7017773 Phase I is in Phase 1 development. One Phase 1 trial has been completed, and no later-stage trials have been registered. The drug remains investigational and has not been approved by the FDA for any indication.

What clinical trials is RO7017773 Phase I in?

RO7017773 Phase I has been studied in one completed Phase 1 trial, NCT03847987. The study assessed the relative bioavailability of a tablet formulation compared with a capsule formulation and the effect of food and taste on the tablet formulation in 24 healthy participants in the United States.

Is RO7017773 Phase I the same as RO7017773 Phase I Capsule?

Yes, RO7017773 Phase I Capsule is another name for RO7017773 Phase I. Both refer to the same Roche small molecule program. The capsule name reflects the capsule formulation used in the Phase 1 trial, which also compared a tablet formulation.