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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04531150 | Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female Subjects | PHASE1 | COMPLETED | 40 | — | — | Sep 8, 2020 | May 16, 2021 | Mar 30, 2025 | 1 | Canada |
Cmax following single dose
AUC following single dose
Half-live following single dose
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Subjects will be randomized to receive either placebo or 20 mg INV-101 |
| Cohort 2 | EXPERIMENTAL | Subjects will be randomized to receive either placebo or 80 mg INV-101 |
| Cohort 3 | EXPERIMENTAL | Subjects will be randomized to receive either placebo or 160 mg INV-101 |
| Cohort 4 | EXPERIMENTAL | Subjects will be randomized to receive either placebo or 320 mg INV-101 |
| Cohort 5 | EXPERIMENTAL | Subjects will be randomized to receive either placebo or 500 mg INV-101 |
| Name | Type | Description |
|---|---|---|
| INV-101 | DRUG | Subjects will be randomized to receive INV-101 tablets |
| Placebo | DRUG | Subjects will be randomized to receive placebo tablets |
Inclusion Criteria: * Healthy adult male or female * Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively; and body weight ≥60 kg * Non- or ex-smoker * Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physica...