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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01999725 | Evaluation of the Safety and Pharmacokinetics of a Single Oral Dose of EDP-788 | PHASE1 | COMPLETED | 80 | — | — | Jan 1, 2014 | Sep 1, 2014 | Jan 9, 2015 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| EDP-788 | EXPERIMENTAL | Single doses with dose escalation to continue in successive cohorts |
| Placebo | PLACEBO_COMPARATOR | Single dose with matching placebo |
| Name | Type | Description |
|---|---|---|
| EDP-788 | DRUG | EDP-788 Capsules and matching placebo capsules. EDP-788 Liquid Suspension and matching placebo. All interventions are given as single doses |
| Placebo | DRUG | Matching placebo capsules or matching suspension |
Key Inclusion Criteria: * In good general health * BMI between 18 - 32 kg/m2 * Women must be of non-childbearing potential (surgically sterilized) * Normal electrocardiogram * Willing to abstain from strenuous physical exercise starting 3 days prior to admission to the study clinic through the 8 - ...