Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ACT-246475 · 3 trials · 3 indications
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Cumulative amount of total 14C-radioactivity excreted in urine and feces will be calculated by summing up the amount of total 14C-radioactivity of the samples excreted in each collection interval
\- IPA%\[MPA\] will be calculated as mean change in percentage from baseline for each time point.
\- IPA%\[PRU\] will be calculated as mean change in percentage from baseline for each time point. Treatment A1: single s.c. dose administration of ACT-246475-matching placebo followed by a single oral dose of clopidogrel (600 mg). Treatment A2: single s.c. dose administration (16 mg) of ACT-246475 followed by a single oral dose of clopidogrel (300 mg). Treatment B1: single s.c. dose administration of ACT-246475-matching placebo followed by a single oral dose of prasugrel (60 mg). Treatment B2: single s.c. dose administration (16 mg) of ACT-246475 followed by a single oral dose of prasugrel (60 mg). Treatment C1: single s.c. dose administration of ACT-246475-matching placebo followed by a single oral dose of ticagrelor (180 mg). Treatment B2: single s.c. dose administration (16 mg) of ACT-246475 followed by a single oral dose of ticagrelor (180 mg).
| Arm | Type | Description |
|---|---|---|
| Treatment period A | EXPERIMENTAL | Treatment A1: saline 0.9% followed by Treatment A2: ACT-246475 |
| Treatment period B | EXPERIMENTAL | Treatment B1: rifampicin followed by Treatment B2: ACT-246475 |
| Treatment and observation period | EXPERIMENTAL | On Day 1, the subjects will receive a single s.c. dose of 16 mg 14C-radiolabeled ACT-246475 in the fasted state. Subjects will be followed by an observation period of 3 days (72 h) during which blood, urine, and feces samples will be collected. |
| Part A: Group 1 | EXPERIMENTAL | Clopidogrel will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax |
| Part A: Group 2 | EXPERIMENTAL | Clopidogrel will be administered 12 h after ACT-246475 or placebo |
| Part A: Group 3 | EXPERIMENTAL | Any time interval up to 24 h between the administration of ACT-246475 or placebo and clopidogrel may be studied |
| Part B: Group 1 | EXPERIMENTAL | Prasugrel will be administered 12 h after ACT-246475 or placebo |
| Part B: Group 2 | EXPERIMENTAL | Any time interval up to 24 h between the administration of ACT-246475 or placebo and prasugrel may be studied |
| Part B: Group 3 | EXPERIMENTAL | Any time interval up to 24 h between the administration of ACT-246475 or placebo and prasugrel may be studied |
| Part C: Group 1 | EXPERIMENTAL | Ticagrelor will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax |
| Part C: Group 2 | EXPERIMENTAL | Any time interval up to 24 h between the administration of ACT-246475 or placebo and ticagrelor may be studied |
| Part C: Group 3 | EXPERIMENTAL | Any time interval up to 24 h between the administration of ACT-246475 or placebo and ticagrelor may be studied |
| Name | Type | Description |
|---|---|---|
| Saline | DRUG | Single i.v. infusion of 100 mL saline 0.9% for 30 min |
| ACT-246475 | DRUG | Single s.c. dose of 4 mg ACT-246475 in the thigh under fasting conditions |
| Rifampicin | DRUG | Single i.v. infusion of 600 mg rifampicin (100 mL) for 30 min |
| Clopidogrel | DRUG | Tablet for oral administration (300 or 600 mg) |
| Prasugrel | DRUG | Tablet for oral administration (60 mg) |
| Placebo | DRUG | Matching ACT-246475 placebo will consist of sterile 0.9% w/v sodium chloride solution |
| Ticagrelor | DRUG | Tablet for oral administration (180 mg) |
Inclusion Criteria: * Signed informed consent in a language understandable to the subject prior to any study-mandated procedure * Healthy male and female subjects aged between 18 and 65 years (inclusive) at Screening * Body mass index of 18.0 to 30.0 kg/m2 (inclusive) at Screening * Systolic blood ...
ACT-246475 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in Phase 1 clinical development. The completed trials evaluated its interactions with other drugs, its fate in the body, and the effect of rifampicin on its uptake and breakdown.
ACT-246475 is being developed by Viatris Inc. (NASDAQ: VTRS). The company is conducting Phase 1 clinical trials to evaluate the drug's safety and pharmacokinetics in healthy subjects.
ACT-246475 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All three clinical trials listed for ACT-246475 are Phase 1 studies that have been completed.
ACT-246475 has completed three Phase 1 trials: NCT03430661, a study of its interaction with clopidogrel, prasugrel, and ticagrelor in healthy subjects; NCT03593278, a study of its fate in healthy male subjects; and NCT03814200, a study of the effect of rifampicin on its uptake and breakdown.
No alternative names for ACT-246475 have been reported. The drug is identified solely by its code name ACT-246475 in clinical trial records.