Ignite Creation Date:
2024-05-06 @ 3:06 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02205073
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
2014-06-19
Brief Title:
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
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-000867-42 | EUDRACT_NUMBER | None | None |