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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03761004 | WD-1603 PK Study in Healthy Volunteers | PHASE1 | COMPLETED | 8 | — | — | Jan 14, 2019 | Sep 5, 2019 | Feb 13, 2020 | 1 | Canada |
the maximum plasma concentrations
the areas under the plasma concentration versus time curve calculated from 0 to the last measurable observation
the areas under the plasma concentration versus time curve extrapolated from 0 to infinity
| Arm | Type | Description |
|---|---|---|
| WD-1603 single dose | EXPERIMENTAL | WD-1603 single dose: A single WD-1603 tablet after breakfast. Plasma samples for PK analysis will be collected at pre-dose (baseline) and 10 min, 30 min, 45 min and 1, 1.5, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 16 and 24 hours post-dose. |
| WD-1603 BID dose | EXPERIMENTAL | WD-1603 BID dose: A single WD-1603 tablet after breakfast, and a second WD-1603 tablet approximately 3 hours after completing lunch. Plasma samples for PK analysis will be collected at pre-dose (baseline) and 10 min, 30 min, 45 min and 1, 1.5, 2, 3, 4, 4.5, 5, 6, 7, 7.25, 7.5, 7.75, 8, 8.5, 9, 10, 10.5 11, 12, 16 and 24 hours post-dose. |
| Sinemet single dose | ACTIVE_COMPARATOR | Sinemet single dose: A single oral dose of Sinemet after breakfast. Plasma samples for PK analysis will be collected at pre-dose (baseline) and 10 min, 30 min, 45 min and 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 16 and 24 hours post-dose. |
| Name | Type | Description |
|---|---|---|
| carbidopa-levodopa | DRUG | single dose of WD-1603, BID dose of WD-1603 and Sinemet IR |
Inclusion Criteria: 1. Healthy adult male or female subjects, 18 to 55 years of age, inclusive, at the time of signing the informed consent form (ICF). 2. A minimum body weight of 50.0 kg (110.0 lbs) and body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening. 3. Non-smoker for a...