Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RDN-929 · 1 trial · 1 indication
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...
RDN-929 is an investigational small molecule being developed by Alkermes plc. It has been studied in a Phase 1 clinical trial in healthy adult and elderly volunteers. Its therapeutic indication has not been disclosed, and it remains in early clinical development rather than being an approved medicine.
RDN-929 is being developed by Alkermes plc, which trades on the Nasdaq under the ticker ALKS. The company sponsored the Phase 1 study of the compound conducted in the Netherlands.
RDN-929 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The compound is investigational and has not been approved by the FDA or any other regulatory agency.
RDN-929 has been evaluated in one completed Phase 1 trial, NCT03668314, titled Single and Multiple Ascending Dose and Food Effect PK Study in Healthy Adult and Elderly Subjects. The study enrolled 84 healthy volunteers aged 18 years and older in the Netherlands and used a randomized, double-blind, placebo-controlled design.
The RDN-929 Phase 1 trial, NCT03668314, was a randomized, double-blind, placebo-controlled study of single and multiple ascending doses with a food effect assessment. It enrolled 84 healthy adult and elderly volunteers of both sexes in the Netherlands and has been completed.