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Healthy VolunteerPhase 1NCT02205073

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

A Phase 1 study testing RG7314 RD + AVP SD in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
RG7314 RD + AVP SD
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteNetherlands
Study dates
Jul 2014to Oct 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Study site

    Leiden, 2333

Other trials in Netherlands

About this study

Official title: 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.

Being tested
Placebo RD + AVP SD, Placebo RD + Placebo SD, RG7314 RD + AVP SD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo RD + AVP SDDrug

    Placebo (matching to study drug) repeat doses + intranasal AVP single dose

  • Placebo RD + Placebo SDDrug

    Placebo (matching to study drug) repeat doses + intranasal Placebo (matching to intranasal AVP) single dose

  • RG7314 RD + AVP SDDrug

    RG7314 repeat doses + intranasal AVP single dose

Study groups in NCT02205073
Study groupRoleWhat they receive
Dosing Period 1Placebo comparatorNot described
Receives: Drug: Placebo RD + Placebo SD
Dosing Period 2Active comparatorNot described
Receives: Drug: Placebo RD + AVP SD
Dosing Period 3ExperimentalNot described
Receives: Drug: RG7314 RD + AVP SD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Replication of AVP-induced inhibition of anterior cingulate cortex (ACC) activity, as measured by BOLD fMRI during a face matching task, differences between treatments

    Measured: After 6 days of dosing with RG7314/placebo and 40 - 130 minutes after application of intranasal vasopressin/placebo

  2. Replication of AVP-induced inhibition of functional connectivity, as measured by BOLD fMRI during a face matching task, differences between treatments

    Measured: After 6 days of dosing with RG7314/placebo and 40 - 130 minutes after application of intranasal vasopressin/placebo

  3. 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

    Measured: After 6 days of dosing with RG7314/placebo and 40 - 130 minutes after application of intranasal vasopressin/placebo

Secondary outcomes (4)

  1. Incidence of adverse events (AEs)

    Measured: Up to 12 weeks

  2. Effect of RG7314 on brain activity modulated by AVP during an implicit and explicit emotional face processing task as evaluated by BOLD fMRI

    Measured: After 6 days of dosing with RG7314/placebo and 40 - 130 minutes after application of intranasal vasopressin/placebo

  3. Effect of RG7314 on brain activity modulated by AVP during a Theory of Mind task, as evaluated by BOLD fMRI

    Measured: After 6 days of dosing with RG7314/placebo and 40 - 130 minutes after application of intranasal vasopressin/placebo

  4. RG7314 plasma concentrations

    Measured: 0h, 2:20h, 3h to 4:30h, 4:30h postdose on Days 6, 20, and 34

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02205073
Sponsor's protocol ID
BP29412
Other IDs
2014-000867-42, 2014
Status last verified
Jul 2016
First submitted
19 Jun 2014
Last updated
4 Jul 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RG7314 RD + AVP SD in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02205073.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2016.

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