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Participants no longer receiving intervention
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Eligibility will be assessed during a screening period of up to 4 weeks. Subjects will take study medication once daily up to and including Day 28. Safety, tolerability and PK will be measured at each visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RDN-929 | Experimental | low, medium and high dose of RDN-929 capsules |
|
| Placebo | Placebo Comparator | Matching placebo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RDN-929 oral capsule | Drug | low, medium and high dose |
| |
| Placebo oral capsule |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | Screening to end of study, up to 9 weeks | up to 9 weeks |
| Number of subjects with Physical exam findings | Screening to end of study, up to 9 weeks | up to 9 weeks |
| Number of subjects with Clinical safety lab changes | Screening to end of study, up to 9 weeks | up to 9 weeks |
| Number of subjects with Systolic blood pressure changes | Screening to end of study, up to 9 weeks | up to 9 weeks |
| Number of subjects with Heart rate changes | Screening to end of study, up to 9 weeks | up to 9 weeks |
| Number of subjects with 12 Lead ECG changes | Screening to end of study, up to 9 weeks | up to 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration, Cmax | RDN-929 and primary metabolite ROD-1610 | Day 1 to Day 28 |
| Area Under the plasma and CSF concentration time curve, AUC | RDN-929 and primary metabolite ROD-1610 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PI | QPS Holdings LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Research Center | Amsterdam | Netherlands | ||||
| QPS Netherlands B.V. |
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| Drug |
matching placebo dose |
|
| Day 1 to Day 28 |
| Leeuwarden |
| Netherlands |