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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02652936 | A Pharmacokinetics Study of AF-130 in Healthy Subjects | PHASE1 | COMPLETED | 80 | — | — | Oct 1, 2015 | Mar 1, 2016 | Dec 6, 2016 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| AF-130 capsule | EXPERIMENTAL | AF-130 oral capsules administered as a single dose or once daily for 7 days |
| AF-130 matching placebo capsule | PLACEBO_COMPARATOR | Oral placebo capsules to match AF-130 administered as a single dose or once daily for 7 days |
| Name | Type | Description |
|---|---|---|
| AF-130 | DRUG | AF-130 oral capsules (50 mg) administered as a single dose or once daily for 7 days |
| Placebo comparator | DRUG | AF-130 matching placebo capsule |
Inclusion Criteria: * Healthy males * Age 18 to 55 years * Body mass index of 18.0 to 35.0 kg/m2 * Willing and able to communicate and participate in the whole study * Must provide written informed consent * Must agree to use an adequate method of contraception Exclusion Criteria: * Participation...