Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
eliglustat; digoxin · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| digoxin | ACTIVE_COMPARATOR | - |
| eliglustat with digoxin | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| eliglustat; digoxin | DRUG | repeat oral doses of 150 mg BID (or 100 mg BID if a CYP2D6 poor metabolizer) eliglustat (Day 11 to Day 17) plus singe dose of digoxin 0.25mg on Day 15 |
| digoxin | DRUG | oral 0.25mg dose of digoxin (single dose) on Day 1 |
Inclusion Criteria: * The male or female subject is in good general health * The subject has a body weight of 50 to 100 kg (110 to 220 lb) with a body mass index (BMI) ≤32 kg/m2 at screening. * The subject's physical examination, laboratory, vital sign, and electrocardiogram (ECG) test results are ...
Eliglustat and digoxin are being studied in a Phase 1 clinical trial in healthy volunteers to evaluate eliglustat's effects on the pharmacokinetics, safety, and tolerability of digoxin. The study is completed and enrolled 28 participants in the United States.
Sanofi (ticker: SNY) is the developer of eliglustat and digoxin. The company conducted a Phase 1 study to assess the drug interaction between eliglustat and digoxin in healthy adults.
Eliglustat and digoxin are in Phase 1 clinical development. The completed trial, NCT01357811, was a Phase 1 study in healthy volunteers. The drug combination is investigational and not approved for any indication.
Eliglustat and digoxin were studied in one completed Phase 1 trial, NCT01357811, titled "A Phase 1 Study Evaluating Eliglustat's Effects on Pharmacokinetics, Safety & Tolerability of Digoxin in Healthy Adults." The trial enrolled 28 healthy adults in the United States.
Eliglustat and digoxin is a combination studied in a drug interaction trial, not a single product. The trial evaluated how eliglustat affects the pharmacokinetics of digoxin. Eliglustat is a small molecule, and digoxin is a cardiac glycoside used as a probe substrate in this study.