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

July 1, 2016 updated by: Hoffmann-La Roche

A RANDOMIZED, DOUBLE-BLIND, THREE PERIOD CROSS-OVER, PLACEBO CONTROLLED, PROOF OF MECHANISM STUDY TO INVESTIGATE THE EFFECT OF RG7314 ON VASOPRESSIN (AVP) PATHWAY ACTIVATION IN HEALTHY MALE SUBJECTS

This is a single site, randomized, double-blind, three period cross-over, placebo-controlled, proof of mechanism study in healthy male subjects. The study will investigate whether the directionality of brain activity and connectivity in response to intranasal vasopressin treatment is similar to earlier studies and explores the effect of short-term treatment with RG7314 on functional MRI as a pharmacodynamic marker. While in the scanner, the participants will be asked to perform a face matching task and a Theory of Mind task, among other assessments. Participants' exposure to study drug will be assessed and all participants will receive follow-up examination 1 and 4 weeks after last dose.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 must be a barrier method for the duration of the study and for 90 days after the last dose
  • In the investigator's opinion, the subject is deemed appropriate for participation in the study, capable of following the study schedule of assessments and complying with the study restrictions and discontinuation of prohibited medication will not pose undue risks to the participants

Exclusion Criteria:

  • History of alcohol and/or substance abuse/dependence
  • History of relapsing or current psychiatric or neurological disorders
  • Participants who, in the Investigator's judgment, pose a suicidal risk, or any subject with a history of suicidal attempts or behavior
  • Positive results for serology test for HIV, Hepatitis B, hepatitis C viruses
  • Confirmed (e.g. 2 consecutive measurements) clinically significant abnormality on 12-lead electrocardiogram (ECG), including a QTcF of >/= 450 milliseconds
  • Confirmed clinically significant abnormality in vital signs, clinical chemistry and/or urinalysis
  • Active stomach ulcer disease or active gastrointestinal bleeding
  • Personal or family history (first or second degree relatives) of cerebral aneurysm
  • Personal history of stroke or traumatic head injury
  • Confirmed clinically significant abnormality in parameters of hematology or coagulation
  • History of coagulopathies, bleeding disorders or blood dyscrasias
  • History of hematological malignancy or myelosuppression (including iatrogenic).
  • Contraindications for MRI scans or any brain/head abnormalities restricting MRI eligibility
  • Fulfillment of any of the MRI contraindications on the standard radiography screening questionnaire
  • Use of prohibited medications within 2 weeks prior to randomization, or 5 half-lives (whichever is longer)
  • Participation in an investigational drug study within 90 days prior to randomization
  • Donation or loss of blood over 500 mL within three months prior to randomization
  • Chronic rhinitis, allergic rhinitis, nasal polyps or any other nasal pathology that may affect the absorption of intranasal AVP according to investigator judgment
  • Concomitant disease, condition or treatment which might interfere with the conduct of the study, or what would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
  • Unwilling or unable to comply with the following lifestyle guidelines: (1) participants will abstain from alcohol for the entire study participation; (2) abstinence from any psychoactive agents or drugs of abuse for the duration of the study period; (3) participants should abstain from unusual strenuous exercise throughout the entire study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Dosing Period 1
Drug: Placebo RD + Placebo SD
Placebo (matching to study drug) repeat doses + intranasal Placebo (matching to intranasal AVP) single dose
Active Comparator: Dosing Period 2
Drug: Placebo RD + AVP SD
Placebo (matching to study drug) repeat doses + intranasal AVP single dose
Experimental: Dosing Period 3
Drug: RG7314 RD + AVP SD
RG7314 repeat doses + intranasal AVP single dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Replication of AVP-induced inhibition of anterior cingulate cortex (ACC) activity, as measured by BOLD fMRI during a face matching task, differences between treatments
Time Frame: After 6 days of dosing with RG7314/placebo and 40 - 130 minutes after application of intranasal vasopressin/placebo
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
Time Frame: After 6 days of dosing with RG7314/placebo and 40 - 130 minutes after application of intranasal vasopressin/placebo
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
Time Frame: After 6 days of dosing with RG7314/placebo and 40 - 130 minutes after application of intranasal vasopressin/placebo
After 6 days of dosing with RG7314/placebo and 40 - 130 minutes after application of intranasal vasopressin/placebo

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of adverse events (AEs)
Time Frame: Up to 12 weeks
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
Time Frame: After 6 days of dosing with RG7314/placebo and 40 - 130 minutes after application of intranasal vasopressin/placebo
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
Time Frame: After 6 days of dosing with RG7314/placebo and 40 - 130 minutes after application of intranasal vasopressin/placebo
After 6 days of dosing with RG7314/placebo and 40 - 130 minutes after application of intranasal vasopressin/placebo
RG7314 plasma concentrations
Time Frame: 0h, 2:20h, 3h to 4:30h, 4:30h postdose on Days 6, 20, and 34
0h, 2:20h, 3h to 4:30h, 4:30h postdose on Days 6, 20, and 34

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 4, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BP29412
  • 2014-000867-42 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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