Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EPX-100 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1 - Itraconazole | EXPERIMENTAL | Treatment A (Period 1): EPX-100 on Day 1. Treatment B (Period 2): itraconazole twice daily (BID) on Day 1; then once daily (QD) on Days 2-5, with EPX-100 administered approximately 2 hours after itraconazole dosing on Day 5. |
| Part 2 - Phenytoin | EXPERIMENTAL | Treatment C (Period 1): EPX-100 on Day 1. Treatment D (Period 2): phenytoin three times daily (TID) on Days 1 to Day 14, with EPX-100 coadministered on the morning of Day 14. |
| Part 3 - Omeprazole, Midazolam, and Bupropion | EXPERIMENTAL | Treatment E (Period 1): omeprazole on Day 1; midazolam on Day 2; bupropion on Day 3. Treatment F (Period 2): EPX-100 BID on Days 1-18 with omeprazole coadministered on the morning of Day 12; midazolam coadministered on the morning of Day 14; bupropion coadministered on the morning of Day 15. |
| Name | Type | Description |
|---|---|---|
| EPX-100 | DRUG | Oral solution |
| Itraconazole | DRUG | Oral solution |
| Phenytoin | DRUG | Phenytoin sodium extended-release capsules |
| Omeprazole | DRUG | Delayed-release capsule |
| Midazolam | DRUG | Midazolam hydrochloride (HCl) syrup |
| Bupropion | DRUG | Bupropion HCl tablets |
Inclusion Criteria: * Healthy, adult, male or female, 18-55 years of age, inclusive, at the screening visit * Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing. * Body mass index ≥18.0 and ≤32.0 kilograms per square mete...