Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Andexanet alfa · 1 trial · 1 indication
To determine the pharmacodynamic (PD) effect of andexanet doses by assessing reversal of rivaroxaban or apixaban anticoagulation measured by chromogenic enzymatic anti-FXa activity assays.
To determine the PD effect of andexanet doses by assessing reversal of rivaroxaban or apixaban anticoagulation measured by chromogenic enzymatic anti-FXa activity assays.
To determine the PD effect of andexanet doses by assessing reversal of rivaroxaban or apixaban anticoagulation measured as thrombin generation potential (including Endogenous Thrombin Potential \[ETP\]).
To determine the PD effect of andexanet doses by assessing reversal of rivaroxaban or apixaban anticoagulation measured as thrombin generation potential (including ETP).
To determine the PD effect of andexanet doses by assessing reversal of rivaroxaban or apixaban anticoagulation measured as thrombin generation potential (including ETP).
To determine the PD effect of andexanet doses by assessing reversal of rivaroxaban or apixaban anticoagulation measured as time to onset of coagulation.
To determine the PD effect of andexanet doses by assessing reversal of rivaroxaban or apixaban anticoagulation measured as time to onset of coagulation.
To determine the PD effect of andexanet doses by assessing reversal of rivaroxaban or apixaban anticoagulation measured as time to onset of coagulation.
To determine anticoagulation by enoxaparin at different time points after andexanet treatment measured by chromogenic enzymatic anti-FXa activity assays.
To determine anticoagulation by enoxaparin at different time points after andexanet treatment measured as thrombin generation potential (including ETP).
| Arm | Type | Description |
|---|---|---|
| Module 1: Rivaroxaban + Andexanet (dose A) | EXPERIMENTAL | Participants will receive once daily dose of 20 mg rivaroxaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before andexanet (dose A) dosing, the participants will receive an additional dose of rivaroxaban. Participants will be further allocated to groups to receive doses of enoxaparin at different time points after the end of andexanet bolus. |
| Module 1: Rivaroxaban + Andexanet (dose B) | EXPERIMENTAL | Participants will receive once daily dose of 20 mg rivaroxaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before andexanet (dose B) dosing, the participants will receive an additional dose of rivaroxaban. |
| Module 1: Rivaroxaban + Andexanet (dose C) | EXPERIMENTAL | Participants will receive once daily dose of 20 mg rivaroxaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before andexanet (dose C) dosing, the participants will receive an additional dose of rivaroxaban. |
| Module 1: Rivaroxaban + Placebo | EXPERIMENTAL | Participants will receive once daily dose of 20 mg rivaroxaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before placebo (equivalent to dose B of andexanet) dosing, the participants will receive an additional dose of rivaroxaban. Participants will be further allocated to groups to receive doses of enoxaparin at different time points after placebo administration. |
| Module 2: Apixaban + Andexanet (dose B) | EXPERIMENTAL | Participants will receive twice daily dose of 5 mg apixaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before andexanet (dose B) dosing, the participants will receive an additional dose of apixaban. Participants will be further allocated to groups to receive doses of enoxaparin at different time points after the end of andexanet bolus. |
| Module 2: Apixaban + Andexanet (dose C) | EXPERIMENTAL | Participants will receive twice daily dose of 5 mg apixaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before andexanet (dose C) dosing, the participants will receive an additional dose of apixaban. |
| Module 2: Apixaban + Andexanet (dose D) | EXPERIMENTAL | Participants will receive twice daily dose of 5 mg apixaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before andexanet (dose D) dosing, the participants will receive an additional dose of apixaban. |
| Module 2: Apixaban + Placebo | EXPERIMENTAL | Participants will receive twice daily dose of 5 mg apixaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before placebo (equivalent to dose B of andexanet) dosing, the participants will receive an additional dose of apixaban. Participants will be further allocated to groups to receive doses of enoxaparin at different time points after placebo administration. |
| Module 3: Rivaroxaban + Andexanet (Dose A) | EXPERIMENTAL | Participants will receive once daily dose of 20 mg rivaroxaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before andexanet (dose A) dosing, the participants will receive an additional dose of rivaroxaban. |
| Module 3: Apixaban + Andexanet (Dose B) | EXPERIMENTAL | Participants will receive twice daily dose of 5 mg apixaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before andexanet (dose B) dosing, the participants will receive an additional dose of apixaban. |
| Module 3: Rivaroxaban + Placebo | EXPERIMENTAL | Participants will receive once daily dose of 20 mg rivaroxaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before placebo (equivalent to dose A of andexanet) dosing, the participants will receive an additional dose of rivaroxaban. |
| Module 3: Apixaban + Placebo | EXPERIMENTAL | Participants will receive twice daily dose of 5 mg apixaban from Day -3 to Day -1 to achieve steady state plasma levels. On Day 1, approximately 3 hours before placebo (equivalent to dose B of andexanet) dosing, the participants will receive an additional dose of apixaban. |
| Module 4: Placebo + Andexanet (dose C) | EXPERIMENTAL | Participants will receive daily dose of one placebo tablet from Day -3 to Day -1. On Day 1, approximately 3 hours before andexanet (dose C) dosing, the participants will receive an additional placebo tablet. |
| Module 4: Placebo + Andexanet (dose B) | EXPERIMENTAL | Participants will receive daily dose of one placebo tablet from Day -3 to Day -1. On Day 1, approximately 3 hours before andexanet (dose B) dosing, the participants will receive an additional placebo tablet. Participants will be further allocated to groups to receive doses of enoxaparin at different time points after the end of andexanet bolus. |
| Name | Type | Description |
|---|---|---|
| Andexanet alfa | DRUG | Andexanet alfa will be administered as an intravenous bolus followed by an infusion, however, in Module 3, only a bolus will be given. |
| Rivaroxaban | DRUG | Rivaroxaban will be administered as an oral tablet. |
| Apixaban | DRUG | Apixaban will be administered as an oral tablet. |
| Enoxaparin | DRUG | Enoxaparin will be administered as a subcutaneous injection. |
| Placebo | OTHER | Placebo will replace andexanet and be given as an IV bolus plus infusion in Modules 1 and 2; in Module 3, placebo will be IV bolus only. In Module 4, an oral placebo tablet will replace rivaroxaban and apixaban. |
Main Inclusion Criteria: * All females must have a negative pregnancy test at the Screening Visit. * Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception. * Sexually active fertile male participan...
Andexanet alfa is being studied in healthy participants as part of a Phase 1 clinical trial. The study investigates Andexanet dosing and the interaction between Andexanet and subsequent enoxaparin in healthy participants. It is an investigational drug and is not approved for any use.
Andexanet alfa is being developed by AstraZeneca PLC, which is listed on the stock exchange under the ticker AZN. The company is conducting clinical research on this drug in healthy participants.
Andexanet alfa is in Phase 1 clinical development. A Phase 1 study has been completed, which involved 191 healthy participants. The drug is investigational and has not been approved by regulatory authorities.
Andexanet alfa has one completed clinical trial, identified as NCT07312851. This study investigated Andexanet dosing and the interaction between Andexanet and subsequent enoxaparin in healthy participants. The trial was conducted in Germany and the United Kingdom.
Yes, Andexanet alfa is classified as a small molecule. It is being studied in a Phase 1 clinical trial that has been completed, involving healthy participants. The trial was controlled and randomized, but not double-blind.