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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03083782 | Drug Interaction Study of Apixaban With Cyclosporine and Tacrolimus | PHASE1 | COMPLETED | 12 | — | — | Apr 18, 2017 | Jun 30, 2017 | Oct 11, 2017 | 1 | United States |
Blood samples for Apixaban pharmacokinetics will be collected prior to apixaban administration at 0H, and then at 1, 2, 3, 4, 6, 12, 24, 48 and, 72 hours in each treatment arm.
Blood samples for Apixaban pharmacokinetics will be collected prior to apixaban administration at 0H, and then at 1, 2, 3, 4, 6, 12, 24, 48 and, 72 hours in each treatment arm.
| Arm | Type | Description |
|---|---|---|
| Treatment A: Apixaban alone | ACTIVE_COMPARATOR | Oral apixaban will be administered in healthy volunteers to define baseline apixaban pharmacokinetics |
| Treatment B: Cyclosporine with apixaban | EXPERIMENTAL | Oral cyclosporine will be administered to steady state in healthy volunteers followed by a single oral dose of apixaban to define apixaban pharmacokinetics in the presence of cyclosporine |
| Treatment C: Tacrolimus with apixaban | EXPERIMENTAL | Oral tacrolimus will be administered to steady state in healthy volunteers followed by a single oral dose of apixaban to define apixaban pharmacokinetics in the presence of tacrolimus |
| Name | Type | Description |
|---|---|---|
| Apixaban alone | DRUG | A single dose of 10 mg apixaban administered orally at 0H on Day 1. |
| Cyclosporine | DRUG | Once daily dose of 100 mg cyclosporine administered orally on Days 1 to 3. |
| Tacrolimus | DRUG | Once daily dose of 5 mg tacrolimus administered orally on Days 1 to 3. |
| Apixaban | DRUG | A single dose of 10 mg apixaban administered orally on Day 3 immediately following cyclosporine |
Inclusion Criteria: 1. Be a healthy male or female between ages 18-55 (inclusive) at the screening visit 2. Have a body mass index (BMI) ≥ 19 and ≤ 33 (inclusive) 3. Be a female subject, subject 1. Can be of childbearing potential and must demonstrate a urine β-hCG level consistent with the non...