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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02666963 | A Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of RTA 901 in Healthy Adults | PHASE1 | COMPLETED | 78 | — | — | Jan 1, 2017 | Jul 23, 2017 | May 29, 2025 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| RTA 901 10 mg or 40 mg or Placebo | EXPERIMENTAL | RTA 901 capsules (10 mg or 40 mg) or placebo taken orally in a single dose. Group 1: RTA 901 10 mg or matching placebo Group 2: RTA 901 20 mg or matching placebo Group 3: RTA 901 ≤ 40 mg or matching placebo Group 4: RTA 901 ≤ 80 mg or matching placebo Group 5: RTA 901 ≤ 160 mg or matching placebo Group 6: RTA 901 ≤ 320 mg or matching placebo Group 7: RTA 901 ≤ 640 mg or matching placebo Dose selection will be based on the safety, tolerability and available pharmacokinetics observed in prior study groups. |
| RTA 901 Dose TBD or Placebo | EXPERIMENTAL | RTA 901 capsules, Dose TBD mg or placebo taken orally once daily for 14 days. Group 8: RTA 901 X mg or matching placebo Group 9: RTA 901 ≤Y mg or matching placebo Group 10: RTA 901 ≤Z mg or matching placebo The actual doses for Arm 2 will be selected based on the safety and available pharmacokinetic data obtained from Arm 1. |
| Name | Type | Description |
|---|---|---|
| RTA 901 Capsules, 10 or 40 mg | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Male or female and age is between 18 and 55 years, inclusive. * Women must be of non-childbearing potential and may not be pregnant, lactating, or breast-feeding. Non-childbearing potential is defined by at least one of the following criteria: 1. At least 2 years spontaneou...