Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Apixaban alone · 1 trial · 3 indications
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...
Apixaban alone is a small molecule being studied for use in venous thromboembolism. It is currently in Phase 1 clinical development as an investigational therapy. The drug is being evaluated in a clinical trial involving healthy volunteers to assess its pharmacokinetics and potential interactions with other medications.
Apixaban alone is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical research on this small molecule for the treatment of venous thromboembolism, a condition involving blood clots in the veins.
Apixaban alone is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, with a total enrollment of 12 participants, and was conducted in the United States.
Apixaban alone has one completed clinical trial registered under NCT03083782, titled "Drug Interaction Study of Apixaban With Cyclosporine and Tacrolimus." This Phase 1 study enrolled 12 participants and was conducted in the United States. The trial was active-controlled and included healthy volunteers.
Apixaban alone refers to the drug apixaban when used as a single agent, without combination with other active substances. In the clinical trial NCT03083782, it is studied as a standalone treatment. The drug is being developed by Bristol-Myers Squibb Company for venous thromboembolism.