Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Genz-112638
eliglustat; digoxin · 2 trials · 2 indications
Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints
Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints
Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints
Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints
Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints
Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints
Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints
Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints
Plasma concentrations of Genz-99067 will be collected at pre-specified timepoints
Total radioactivity excreted in urine and feces will be converted to percentage of radioactive dose.
Total radioactivity in whole blood and plasma will be converted to ngEq/g Genz-99067 concentration for whole blood and ngEq/mL for plasma, based on the dose specific activity.
It will be estimated as \[(radioactivity for the HPLC peak)/(total radioactivity injected per HPLC run) x 100\].
It will be estimated as \[(% relative abundance)/100 x (percentage of radioactive dose in the sample)\].
It will be converted to equivalent concentrations as \[(% relative abundance)/100 x (equivalent concentration of total radioactivity in the sample)\].
| Arm | Type | Description |
|---|---|---|
| digoxin | ACTIVE_COMPARATOR | - |
| eliglustat with digoxin | EXPERIMENTAL | - |
| Treatment Period 1 -2 | EXPERIMENTAL | Single-dose Intravenous (IV) Genz-112638 Day 1 followed by single dose GenZ-112638 oral capsules Day 8 |
| Treatment Period 1-4 | EXPERIMENTAL | Single-dose Intravenous (IV) Genz-112638 Day 1; single dose GenZ-112638 oral capsules Day 8; oral capsule Genz-112638 Days 9-14; single dose \[14C\]-Genz-112638 oral solution Day 15 |
| 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 |
| Genz-112638 | DRUG | Pharmaceutical form:Solution-Route of administration:IV |
| [14C]-Genz-112638 | DRUG | Pharmaceutical form:Solution-Route of administration:Oral |
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 is a small molecule drug developed by Sanofi (ticker SNY). It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United States. The trial evaluated eliglustat's effects on the pharmacokinetics, safety, and tolerability of digoxin. Eliglustat is not described as approved in the available information and remains an investigational agent.
Eliglustat has been studied in a Phase 1 trial in healthy volunteers to assess its effects on digoxin pharmacokinetics, safety, and tolerability. No specific disease indication is disclosed for this study. The trial was active-controlled and completed, with 28 participants enrolled.
Eliglustat is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the Phase 1 trial NCT01357811, which evaluated eliglustat's effects on digoxin in healthy adult volunteers.
Eliglustat is in Phase 1 clinical development. One Phase 1 trial, NCT01357811, has been completed. That study enrolled 28 healthy adult volunteers and was active-controlled. No later-phase trials are listed for eliglustat in this program.
Eliglustat has been 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 volunteers in the United States and was active-controlled.
No, eliglustat and digoxin are different drugs. Eliglustat is a small molecule developed by Sanofi. Digoxin is a separate medication used as the comparator in the Phase 1 trial NCT01357811, which assessed how eliglustat affects digoxin's pharmacokinetics, safety, and tolerability in healthy adults.