Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Genz-112638 · 1 trial · 1 indication
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 |
|---|---|---|
| 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 |
|---|---|---|
| Genz-112638 | DRUG | Pharmaceutical form:Solution-Route of administration:IV |
| [14C]-Genz-112638 | DRUG | Pharmaceutical form:Solution-Route of administration:Oral |
Inclusion Criteria: Having given written informed consent prior to undertaking any study-related procedure The subject has a body weight of 50 to 100 kg \[110 to 220 pounds (lb)\] with a body mass index (BMI) less than 30 kilograms per square meter (kg/m2) at Screening. The subject's physical exami...
Genz-112638 is an investigational small molecule being developed for the treatment of Gaucher's Disease Type I, a rare genetic disorder. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied to evaluate its absorption, metabolism, and excretion in the body.
Genz-112638 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. The drug is in early-stage clinical development for Gaucher's Disease Type I, a rare disease indication.
Genz-112638 is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved for commercial use. The ongoing research is focused on understanding the drug's pharmacokinetics, including its bioavailability, absorption, metabolism, and excretion in healthy volunteers.
Genz-112638 has one completed Phase 1 clinical trial registered under the identifier NCT06143904. This study evaluated the absolute bioavailability, absorption, metabolism, and excretion of the drug in healthy male participants aged 18 years and older. The trial enrolled 10 participants and was a controlled study.
Genz-112638 is the developmental code name for the drug also known as eliglustat. It is being developed by Sanofi for the treatment of Gaucher's Disease Type I. The drug is currently in Phase 1 clinical trials to assess its pharmacokinetic properties.