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RG7314 RD+ AVP SD

Phase 1

Healthy Volunteer | Small molecule | Other |Roche Holding AG|Last 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

Clinical trial landscape

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 Volunteer

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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

Arm	Type	Description
Dosing Period 1	PLACEBO_COMPARATOR	-
Dosing Period 2	ACTIVE_COMPARATOR	-
Dosing Period 3	EXPERIMENTAL	-

Interventions

Name	Type	Description
Placebo RD + AVP SD	DRUG	Placebo (matching to study drug) repeat doses + intranasal AVP single dose
Placebo RD + Placebo SD	DRUG	Placebo (matching to study drug) repeat doses + intranasal Placebo (matching to intranasal AVP) single dose
RG7314 RD + AVP SD	DRUG	RG7314 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 used for?

RG7314 RD+ AVP SD is an investigational small molecule being studied in healthy volunteers. It is being evaluated in a Phase 1 clinical trial to assess its potential regulation of higher brain functions. The drug is not approved for any indication and is still in clinical development.

Who makes RG7314 RD+ AVP SD?

RG7314 RD+ AVP SD is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 1 clinical trial of the drug in healthy male participants.

What phase is RG7314 RD+ AVP SD in?

RG7314 RD+ AVP SD is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under investigation.

What clinical trials is RG7314 RD+ AVP SD in?

RG7314 RD+ AVP SD has one completed clinical trial, NCT02205073. This was a Phase 1, randomized, double-blind, placebo-controlled crossover study in healthy male participants in the Netherlands, with 32 enrolled subjects. The trial evaluated the drug's potential regulation of higher brain functions.

Is RG7314 RD+ AVP SD the same as RG7314?

RG7314 RD+ AVP SD is a formulation of RG7314, the investigational drug being studied in the Phase 1 trial NCT02205073. The trial title refers to RG7314, and the drug is being developed by Roche Holding AG.