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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05797753 | A Study to Assess the Effect of Erythromycin on the Test Medicine (SAR443820) When Given Orally as Tablets to Healthy Adult Male and Female Participants (Part A); and the Effect of Itraconazole on the Test Medicine (SAR443820) When Given Orally as Capsules to Healthy Adult Male Participants (Part B) | PHASE1 | COMPLETED | 16 | — | — | Feb 18, 2022 | Jul 1, 2022 | Jan 3, 2025 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Part-A, Period-1 | EXPERIMENTAL | Single dose of SAR443820 tablet on Day 1 |
| Part-A, Period-2 | EXPERIMENTAL | Single dose of SAR443820 tablet on Day 6, and erythromycin ethyl succinate (EES) three-time a day (TID) from Day 1 to Day 9 |
| Part-B, Period-1 | EXPERIMENTAL | Single dose of SAR443820 capsule on Day 1 |
| Part-B, Period-2 | EXPERIMENTAL | Single dose of SAR443820 capsule on Day 6, and Itraconazole once daily (QD) from Day 1 to Day 11 |
| Name | Type | Description |
|---|---|---|
| SAR443820 | DRUG | Tablet by oral administration |
| Erythromycin ethyl succinate | DRUG | Tablet by oral administration |
| Itraconazole | DRUG | Capsule by oral administration |
Inclusion Criteria: * Part A: male or female participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent * Part B: male participant only must be 18 to 55 years of age inclusive, at the time of signing the informed consent * Body weight between 50.0 and 100.0 kg,...