Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Selatogrel · 7 trials · 6 indications
The clinical status will be assessed using a 6-point ordinal scale after any study treatment self-administration. Only the worst clinical outcome will be retained as the primary efficacy outcome. The 6 mutually exclusive outcomes ranked from worst to best are: 1. Death (all causes), within 7 days after study treatment administration. 2. Acute myocardial infarction with compromised electro-hemodynamics, within 2 days after study treatment administration. 3. ST-Elevation Myocardial Infarction (STEMI), within 2 days after study treatment administration. 4. High-risk Non-ST-Elevation Myocardial Infarction (NSTEMI), within 2 days after study treatment administration. 5. NSTEMI with peak cardiac troponin greater than 10 times upper limit of normal, within 2 days after study drug administration. 6. None of the above
The number of: * Type 3 treatment-emergent bleeding events and * Type 5 treatment-emergent bleeding events will be assessed according to the Bleeding Academic Research Consortium (BARC) definition (Mehran et al. 2011), within 2 days after study treatment administration. The Bleeding Academic Research Consortium (BARC) definitions are: * Type 3, bleeding is divided into 3 categories, a through c, and includes clinical, laboratory, and/or imaging evidence of bleeding with specific healthcare provider responses. * Type 5, bleeding is fatal.
The pharmacodynamic response was determined by measuring the inhibition of platelet aggregation, using the VerifyNow® assay. The VerifyNow® is a point-of-care test measuring platelet reactivity. The results are expressed as P2Y12 reaction units (PRU).The target of 100 PRU corresponds to 80% inhibition of ADP-induced platelet aggregation. A participant with a PRU less than 100 at 30 minutes post-dose was counted as a participant that had a pharmacodynamic response.
The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles
The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles
The measured individual plasma concentrations of selatogrel will be used to directly obtain Cmax
The measured individual plasma concentrations of selatogrel will be used to directly obtain tmax
The plasma selatogrel PK parameters will be derived by non compartmental analysis of the concentration-time profiles
| Arm | Type | Description |
|---|---|---|
| Selatogrel | EXPERIMENTAL | Study treatment administration may occur at any time between the randomization visit and the final study visit when the participant experiences symptoms suggestive of an acute myocardial infarction. Study treatment administration triggers protocol pre-defined assessments or visits. |
| Placebo | PLACEBO_COMPARATOR | Study treatment administration may occur at any time between the randomization visit and the final study visit when the participant experiences symptoms suggestive of an acute myocardial infarction. Study treatment administration triggers protocol pre-defined assessments or visits. |
| Selatogrel 8 mg | EXPERIMENTAL | Selatogrel (ACT-246475) is given as a single subcutaneous dose of 8 mg administered in a volume of 0.8 mL. Administration will be performed at the investigational site by qualified personnel. |
| Selatogrel 16 mg | EXPERIMENTAL | Selatogrel (ACT-246475) is given as a single subcutaneous dose of 16 mg administered in a volume of 0.8 mL. Administration will be performed at the investigational site by qualified personnel. |
| Treatment A: liquid formulation via auto-injector | EXPERIMENTAL | Selatogrel will be administered as a liquid formulation in a sealed prefilled syringe in an auto-injector forming an integral ready-to-use single-dose drug delivery system. |
| Treatment B: liquid formulation via syringe | EXPERIMENTAL | Selatogrel will be administered as a liquid formulation in a sealed prefilled syringe. |
| Treatment C: lyophilizate-based formulation via syringe | EXPERIMENTAL | Selatogrel will be administered as a reconstituted lyophilizate-based formulation for injection. |
| Participants with mild hepatic impairment (Group 1) | EXPERIMENTAL | Participant with Child-Pugh Grade A Score of 5-6. |
| Participants with moderate hepatic impairment (Group 2) | EXPERIMENTAL | Participant with moderate hepatic impairment with a Child-Pugh Grade B Score of 7-9. |
| Healthy participants (Group 3) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Selatogrel | COMBINATION_PRODUCT | Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. Selatogrel will be administered as a liquid formulation in a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system. Participants will self-administer 16 mg of selatogrel subcutaneously with the autoinjector upon occurrence of symptoms suggestive of an acute myocardial infarction. Self-administration encompasses the use of the autoinjector by another person (e.g., partner, close relative, friend, caregiver) who may be called for help during the emergency situation of a suspected AMI. |
| Placebo | COMBINATION_PRODUCT | Placebo will be administered as a liquid formulation in a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system. Participants will self-administer placebo subcutaneously with the autoinjector upon occurrence of symptoms suggestive of an acute myocardial infarction. Self-administration encompasses the use of the autoinjector by another person (e.g., partner, close relative, friend, caregiver) who may be called for help during the emergency situation of a suspected AMI. |
| Selatogrel 8 mg | DRUG | Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water and further diluted with 1 mL sodium chloride (NaCl) 0.9%. |
| Selatogrel 16 mg | DRUG | Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water for injection. |
| Matching placebo | COMBINATION_PRODUCT | A single dose of placebo will be administered as a liquid formulation from a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system. |
Main Inclusion Criteria: * Confirmed diagnosis of symptomatic type 1 acute myocardial infarction (AMI) ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial Infarction (NSTEMI), no longer than 4 weeks prior to randomization. * Diagnosis of multivessel coronary artery disease def...
Selatogrel is an investigational small molecule being studied for use in acute myocardial infarction (heart attack), stable coronary artery disease, and chronic coronary syndrome. It is also studied in healthy subjects and volunteers for research purposes. The drug is in Phase 3 clinical development for suspected acute myocardial infarction.
Selatogrel is a small molecule that targets the P2Y12 receptor on platelets, inhibiting platelet aggregation. By blocking this receptor, it reduces the ability of platelets to clump together and form clots, which is relevant in acute myocardial infarction and other cardiovascular conditions.
Selatogrel is being developed by Viatris Inc., a pharmaceutical company traded on the NASDAQ under the ticker symbol VTRS. The company is conducting clinical trials to evaluate the drug's safety and efficacy for cardiovascular indications.
Selatogrel is in Phase 3 clinical development. The most advanced trial, NCT04957719, is a Phase 3 outcome study in suspected acute myocardial infarction with an enrollment of 25,000 participants. Earlier Phase 1 and Phase 2 studies have been completed.
Selatogrel has been studied in several clinical trials. NCT04957719 is a Phase 3 outcome study in suspected acute myocardial infarction, currently enrolling by invitation. Completed trials include NCT03487445 (Phase 2 in acute myocardial infarction), NCT04406896 (Phase 1 in hepatic impairment), and NCT04557280 (Phase 1 in healthy subjects).
Yes, Selatogrel is also known as ACT-246475. Clinical trial records reference both names, with NCT03487445 titled 'A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Heart Attack' and other studies using the name Selatogrel.