Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03668314 | Single and Multiple Ascending Dose and Food Effect PK Study in Healthy Adult and Elderly Subjects | PHASE1 | COMPLETED | 84 | — | — | Oct 10, 2018 | Apr 15, 2019 | Feb 20, 2020 | 1 | Netherlands |
Listing and summary of AE incidence
Listing of clinically significant changes in PE findings
Listing and change from baseline to end of study
Listing and change from baseline to end of study
Listing and change from baseline to end of study
Change in 12-lead ECG parameters from baseline to end of study
Listing of findings
Listing of results
VAS for headache and nausea
| Arm | Type | Description |
|---|---|---|
| Cohort 1:1 - 1:6 RDN-929 | EXPERIMENTAL | RDN-929 single dose capsule |
| Cohort 1:1 - 1:6 placebo | PLACEBO_COMPARATOR | Placebo single dose capsule |
| Cohort 2:1 | EXPERIMENTAL | Fed/Fast RDN-929 |
| Cohort 3:1- 3:4 RDN-929 | EXPERIMENTAL | RDN-929 multiple dose capsules once daily for 12 days |
| Cohort 3:1- 3:4 placebo | PLACEBO_COMPARATOR | placebo multiple dose capsules once daily for 10 days |
| Name | Type | Description |
|---|---|---|
| RDN-929 | DRUG | Single dose from 2 mg to TBD |
| Placebo oral capsule | DRUG | Matching placebo Single dose |
| RDN-929 TBD dose | DRUG | Fed vs fast dose TBD based upon results of previous cohorts |
Inclusion Criteria: * Healthy as determined by the Investigator, based on a medical evaluation including medical history physical examination, neurological examination, laboratory tests and cardiac monitoring * Men, age 18-54 years inclusive at Screening (Part 1) or men and postmenopausal or surgic...