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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04092751 | Study to Evaluate the Effect of SCY-078 (Ibrexafungerp) on the PK of Pravastatin in Healthy Subjects | PHASE1 | COMPLETED | 28 | — | — | Nov 22, 2019 | Dec 20, 2019 | Sep 2, 2020 | 1 | Australia |
AUC 0-24 of PRA when taken with SCY-078.
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | Single oral 20-mg dose of PRA on Day 1 AM |
| Treatment B | EXPERIMENTAL | Twice daily (BID), every 12 hours (Q12H) oral doses of SCY-078 750 mg on Day 1 and Day 2; and on Day 3 a single AM dose of oral SCY 078 750 mg followed by a single 20-mg dose of PRA administered one hour later. |
| Name | Type | Description |
|---|---|---|
| PRA | DRUG | Single oral 20-mg dose of PRA on Day 1 AM |
| SCY-078 plus PRA | DRUG | Twice daily (BID), every 12 hours (Q12H) oral doses of SCY-078 750 mg on Day 1 and Day 2; and on Day 3 a single AM dose of oral SCY 078 750 mg followed by a single 20-mg dose of PRA administered one hour later |
Inclusion Criteria: 1. is a male or female between 18 to 55 years, inclusive, of age at the prestudy (screening) visit (time of signing the Informed Consent). 2. has a Body Mass Index (BMI) 18.0 to 32 kg/m2 at the prestudy (screening) visit. 3. is judged to be in good health based on medical histor...