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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04092725 | Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects | PHASE1 | COMPLETED | 36 | — | — | Sep 9, 2019 | Jan 3, 2020 | Sep 2, 2020 | 1 | Australia |
AUC0-48 of DAB when taken with SCY-078
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | Single oral 150-mg dose of DAB 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 single oral AM doses of SCY-078 750 mg on Day 3 and Day 4. On Day 3 a single 150-mg dose of DAB will be administered one hour after the AM dose of SCY-078. |
| Name | Type | Description |
|---|---|---|
| DAB | DRUG | Single oral 150-mg dose of DAB on Day 1 AM. |
| SCY-078 plus DAB | DRUG | Twice daily (BID), every 12 hours (Q12H) oral doses of SCY-078 750 mg on Day 1 and Day 2; and single oral AM doses of SCY-078 750 mg on Day 3 and Day 4. On Day 3 a single 150-mg dose of DAB will be administered one hour after the AM dose of SCY-078. |
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 - 32 kg/m2 at the prestudy (screening) visit. BMI is calculated by taking the subject's weight in kg and...