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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04044339 | Single and Multiple Ascending Dose, First-in- Human Study in Healthy Subjects | PHASE1 | COMPLETED | 56 | — | — | Aug 8, 2019 | Nov 27, 2019 | Jan 14, 2021 | 1 | United States |
Area under the plasma concentration-time curve (AUC)
Maximum observed concentration (Cmax)
Time to reach maximum observed concentration (Tmax)
Oral Clearance (CL/F)
Terminal Phase Volume of Distribution(Vz/F)
Elimination Rate (Kel)
Halflife (t 1/2)
Area under the plasma concentration-time curve (AUC)
Maximum observed concentration (Cmax)
Time to reach maximum observed concentration (Tmax)
concentration at trough (after multiple dosing usually after reaching steady state) (C trough)
concentration at steady state (Css)
Oral clearance at steady state (CL/Fss)
Concentration minimum (after single dosing) (Cmin)
Terminal phase volume of distribution at steady state (Vz/Fss)
Elimination Rate (Kel)
Halflife (t 1/2)
| Arm | Type | Description |
|---|---|---|
| TD-5202 for SAD (Part A) | EXPERIMENTAL | 6 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive TD-5202 |
| Placebo for SAD (Part A) | PLACEBO_COMPARATOR | 2 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive placebo |
| TD-5202 for MAD (Part B) | EXPERIMENTAL | 6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-5202 |
| Placebo for MAD (Part B) | PLACEBO_COMPARATOR | 2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo. |
| Name | Type | Description |
|---|---|---|
| TD-5202 | DRUG | Study Drug to be administered orally |
| Placebo | DRUG | Placebo to be administered orally |
Inclusion Criteria: * Male or female, 19 - 55 years old * Willing and able to give informed consent and comply with the study * Medically healthy with no clinically significant medical history * Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg * Women of child bearing potential must h...