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RG7314 RD+ AVP SD

Phase 1

Undisclosed | Small molecule | Other |Roche Holding AG|Trials Updated: Jul 4, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

RG7314 RD+ AVP SD clinical trials

RG7314 RD+ AVP SD · 1 trial · 1 indication

Phase 1 1
NCT02205073A Phase 1, Randomized, Double-blind, Placebo-controlled Crossover Study of RG7314 on the Potential Regulation of Higher Brain Functions in Healthy Male Participants: Proof of MechanismHealthy Volunteer
COMPLETED32 Analytics
PHASE1COMPLETED
A Phase 1, Randomized, Double-blind, Placebo-controlled Crossover Study of RG7314 on the Potential Regulation of Higher Brain Functions in Healthy Male Participants: Proof of Mechanism
Healthy VolunteerUnlock trial analytics

Study Endpoints

Primary Endpoints

Replication of AVP-induced inhibition of anterior cingulate cortex (ACC) activity, as measured by BOLD fMRI during a face matching task, differences between treatments
After 6 days of dosing with RG7314/placebo and 40 - 130 minutes after application of intranasal vasopressin/placebo
Replication of AVP-induced inhibition of functional connectivity, as measured by BOLD fMRI during a face matching task, differences between treatments
After 6 days of dosing with RG7314/placebo and 40 - 130 minutes after application of intranasal vasopressin/placebo
Effect of RG7314 on the modulation of AVP pathway effects on ACC activity, as measured by BOLD fMRI during a face matching task, differences between treatments
After 6 days of dosing with RG7314/placebo and 40 - 130 minutes after application of intranasal vasopressin/placebo

Secondary Endpoints

Incidence of adverse events (AEs)
Up to 12 weeks
Effect of RG7314 on brain activity modulated by AVP during an implicit and explicit emotional face processing task as evaluated by BOLD fMRI
After 6 days of dosing with RG7314/placebo and 40 - 130 minutes after application of intranasal vasopressin/placebo
Effect of RG7314 on brain activity modulated by AVP during a Theory of Mind task, as evaluated by BOLD fMRI
After 6 days of dosing with RG7314/placebo and 40 - 130 minutes after application of intranasal vasopressin/placebo
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Dosing Period 1PLACEBO_COMPARATOR -
Dosing Period 2ACTIVE_COMPARATOR -
Dosing Period 3EXPERIMENTAL -

Interventions

NameTypeDescription
Placebo RD + AVP SDDRUGPlacebo (matching to study drug) repeat doses + intranasal AVP single dose
Placebo RD + Placebo SDDRUGPlacebo (matching to study drug) repeat doses + intranasal Placebo (matching to intranasal AVP) single dose
RG7314 RD + AVP SDDRUGRG7314 repeat doses + intranasal AVP single dose
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Right-handed, healthy non-smoker male adults, 18 to 45 years of age * A body mass index between 18 to 32 kg/m2 inclusive and total weight in the range of 50-100 kg * Participants and their partners of childbearing potential must use 2 methods of contraception, one of which mus...

Countries:Netherlands
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Frequently asked questions about RG7314 RD+ AVP SD

What is RG7314 RD+ AVP SD?

RG7314 RD+ AVP SD is an investigational small molecule developed by Roche Holding AG. It has been studied in a Phase 1 proof-of-mechanism trial in healthy male volunteers, evaluating its potential regulation of higher brain functions. The specific therapeutic indication for this asset has not been disclosed.

Who makes RG7314 RD+ AVP SD?

RG7314 RD+ AVP SD is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the Phase 1 study of the compound. No partnership or licensing arrangement for this asset has been disclosed.

What phase is RG7314 RD+ AVP SD in?

RG7314 RD+ AVP SD is in Phase 1 development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for this asset.

What clinical trials is RG7314 RD+ AVP SD in?

RG7314 RD+ AVP SD has been evaluated in one completed Phase 1 trial, NCT02205073. The study was a randomized, double-blind, placebo-controlled crossover trial of 32 healthy male participants in the Netherlands, designed as a proof-of-mechanism study of the compound's effects on higher brain functions.

What is RG7314 RD+ AVP SD used for?

RG7314 RD+ AVP SD has been studied in healthy male volunteers rather than in a patient population, and its target indication has not been disclosed. The completed Phase 1 trial, NCT02205073, examined the compound's potential regulation of higher brain functions as a proof of mechanism.