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Tebipenem pivoxil hydrobromide · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| TBPM-PI-HBr Alone (Period 1) | EXPERIMENTAL | Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally alone. |
| TBPM-PI-HBr and Antacid (Period 2) | EXPERIMENTAL | 20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL) oral suspension will be coadministered with 600 mg (2 x 300 mg tablets) TBPM-PI-HBr at Hour 0 on Day 1. |
| TBPM-PI-HBr and Omeprazole (Period 3) | EXPERIMENTAL | 40 mg (1 x 40 mg capsule) omeprazole administered QD at Hour -2 on Days 1 through 5, with 600 mg (2 x 300 mg tablets) TBPM-PI-HBr administered at Hour 0 on Day 5. |
| Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) | EXPERIMENTAL | Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally. |
| Name | Type | Description |
|---|---|---|
| Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) | DRUG | Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally. |
| 20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL) | DRUG | 20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL) oral suspension. |
| Omeprazole | DRUG | 40 mg (1 x 40 mg capsule) omeprazole administered QD |
Key Inclusion Criteria: * Healthy, adult, male or female, 18-55 years of age, inclusive, at the screening visit. * Continuous non-smoker * Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit. * Medically healthy with no clinically significant medical history, physical examination, ...
Tebipenem pivoxil hydrobromide is an investigational small molecule being studied for use in renal impairment and in healthy volunteers. It is being developed by Spero Therapeutics, Inc. (NASDAQ: SPRO). The drug is currently in Phase 1 clinical development.
Tebipenem pivoxil hydrobromide is being developed by Spero Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker SPRO. The company is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetics and safety.
Tebipenem pivoxil hydrobromide is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, one in subjects with renal impairment and one in healthy volunteers.
Tebipenem pivoxil hydrobromide has completed two Phase 1 trials. NCT04178577 studied its pharmacokinetics and safety in subjects with various degrees of renal function, enrolling 39 participants. NCT04368585 examined the effect of antacid and omeprazole on its pharmacokinetics in 20 healthy adults.
Yes, Tebipenem pivoxil hydrobromide is also known as TBPM-PI-HBr. Clinical trial records refer to the drug by this abbreviation, for example in the Phase 1 study of its pharmacokinetics in subjects with renal impairment and in the study of its interaction with antacid and omeprazole.