Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03687554 | Effect of Venglustat in Patients With Renal Impairment | PHASE1 | COMPLETED | 24 | — | — | Oct 5, 2018 | Feb 27, 2019 | Apr 25, 2022 | 1 | United States |
Venglustat area under the plasma concentration versus time curve (AUC)
| Arm | Type | Description |
|---|---|---|
| Venglustat | EXPERIMENTAL | Single dose of Venglustat is given, orally under fasting conditions |
| Name | Type | Description |
|---|---|---|
| Venglustat GZ/SAR402671 | DRUG | Pharmaceutical form: Hard Capsule Route of administration: Oral |
Inclusion criteria: For all Subjects: * Male and/or female subjects, between 18 and 79 years of age, inclusive. * Body weight between 50.0 and 115.0 kg, inclusive, if male, and between 40.0 and 100.0 kg, inclusive, if female, body mass index between 18.0 and 34.9 kg/m2, inclusive * Normal electroc...