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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04973657 | A Study to Assess the Pharmacodynamics of VK0214 in Male Subjects With AMN | PHASE1 | COMPLETED | 24 | — | — | Jun 22, 2021 | Nov 8, 2024 | Feb 17, 2025 | 9 | United States, France +3 |
Evaluate the safety and tolerability of multiple oral doses of VK0214 in subjects with AMN
| Arm | Type | Description |
|---|---|---|
| VK0214 Active 20mg | EXPERIMENTAL | 20mg QD |
| VK0214 Active 40mg | EXPERIMENTAL | 40mg QD |
| Placebo | PLACEBO_COMPARATOR | Placebo QD |
| Name | Type | Description |
|---|---|---|
| VK0214 | DRUG | API in capsule |
| Placebo | OTHER | API in capsule |
Inclusion Criteria: * Provide a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and is willing and able to participate. * Have diagnosis of X-linked adrenoleukodystrophy (X-ALD) by genetic testing and elevated...