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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000867-42 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosing Period 1 | Placebo Comparator |
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| Dosing Period 2 | Active Comparator |
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| Dosing Period 3 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo RD + AVP SD | Drug | Placebo (matching to study drug) repeat doses + intranasal AVP single dose |
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| Measure | Description | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden | 2333 | Netherlands |
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| Placebo RD + Placebo SD | Drug | Placebo (matching to study drug) repeat doses + intranasal Placebo (matching to intranasal AVP) single dose |
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| RG7314 RD + AVP SD | Drug | RG7314 repeat doses + intranasal AVP single dose |
|
| 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 |
| RG7314 plasma concentrations | 0h, 2:20h, 3h to 4:30h, 4:30h postdose on Days 6, 20, and 34 |