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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07119073 | In-clinic Crossover Study in Subjects With Two Treatments (Fed vs Fasted) | PHASE1 | COMPLETED | 25 | — | — | Oct 31, 2024 | Dec 27, 2024 | Aug 12, 2025 | 1 | United States |
| NCT04449250 | Fed-Fast Crossover Study to Assess the Effect of Food With CTx-1301 in Healthy Subjects | PHASE1 | COMPLETED | 27 | — | — | Sep 14, 2022 | Oct 14, 2022 | Oct 20, 2022 | 1 | United States |
Maximum Concentration
Area Under the Curve from time 0 to infinity
Area Under the Curve from time 0 to 28 hrs
| Arm | Type | Description |
|---|---|---|
| CTx-1301 Fasted | ACTIVE_COMPARATOR | Subjects will receive CTx-1301 in a fasted state |
| CTx-1301 Fed | ACTIVE_COMPARATOR | Subjects will receive CTx-1301 in a fed state (high fat test meal) |
| Name | Type | Description |
|---|---|---|
| Dexmethylphenidate | DRUG | Subjects will be randomized to one of two sequences. Subjects will be dosed with 50 mg dose of Cox-1301 during each sequence. Subjects will serve as their own control. |
Inclusion Criteria: 1. Gender a. Male or Female 2. Age 1. Aged between 18 and 50 years inclusive. Weight and BMI <!-- --> 1. Body weight ≥ 50 kg 2. BMI ≥ 18 and ≤ 30 4\. Compliance 1. Understands and is willing, able, and likely to comply with all study procedures and restricti...