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This two-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of RO5285119 in healthy volunteers. Anticipated time on study will be up to 9 weeks for each subject.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5285119 | Drug | single and multiple ascending oral doses |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | up to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the concentration - time curve (AUC) | up to 5 weeks | |
| Pharmacodynamics (neurological effects): Profile of Mood States/Bond&Lader VAS/smell test/C-SSRS | up to 5 weeks | |
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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 |
|---|---|---|---|---|---|---|
| Rennes | 35042 | France | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34176392 | Derived | Derks M, Lennon-Chrimes S, Guenther A, Squassante L, Wandel C, Szczesny P, Paehler A, Kletzl H. Bioavailability and pharmacokinetic profile of balovaptan, a selective, brain-penetrant vasopressin 1a receptor antagonist, in healthy volunteers. Expert Opin Investig Drugs. 2021 Aug;30(8):893-901. doi: 10.1080/13543784.2021.1948009. Epub 2021 Jul 16. |
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| Drug |
single and multiple oral doses |
|
| Pharmacodynamics: Biomarker levels (ACTH, prolactin, cortisol, vasopressin) |
| up to 5 weeks |
| Pharmacodynamics: Functional Magnetic Resonance Imaging | up to 5 weeks |
| Food effect: Comparison of single dose pharmacokinetics (AUC) in fasted and fed state (Part 1b) | up to 5 weeks |
| Strasbourg |
| 67064 |
| France |