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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05296382 | Bioavailability of Tebipenem (SPR994) Crushed Tablet | PHASE1 | COMPLETED | 12 | — | — | Apr 1, 2022 | Dec 23, 2022 | Feb 28, 2024 | 1 | United States |
Tebipenem total and free blood concentrations following the tebipenem dose (intact)
| Arm | Type | Description |
|---|---|---|
| Crushed Tebipenem Tablet with Tube feeds | EXPERIMENTAL | Crushed tebipenem tablets will be administered by syringe through the nasogastric tube and flushed with water to ensure all drug is passed through. Subjects will also receive concurrent enteral tube feeds (feeds run for 2h before dose and 4h post-dose). |
| Whole Tebipenem Tablet | EXPERIMENTAL | Tebipenem tablet will be swallowed whole without crushing. |
| Crushed Tebipenem Tablet without Tube feeds | EXPERIMENTAL | Crushed tebipenem tablets will be administered by syringe through the nasogastric tube and flushed with water to ensure all drug is passed through. |
| Name | Type | Description |
|---|---|---|
| Tebipenem tablet form | DRUG | Tebipenem tablets will be administered intact or crushed |
| Tube feeds | OTHER | Tebipenem tablets will be administered with or without tube feeds |
Inclusion Criteria: 1. Willing to participate in the trial, give written informed consent, and comply with the trial restrictions. 2. Gender: male or female with a negative serum pregnancy test (β-human chorionic gonadotropin) at Screening and Day -1; females may be of childbearing potential or of ...