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To assess the effect of a single dose of aluminum hydroxide/magnesium hydroxide/simethicone and omeprazole on the pharmacokinetics (PK) of TBPM, following a single dose of TBPM-PI-HBr in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) | Drug | Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t). | Day 2 (Periods 1 and 2) and Day 6 (Period 3) | |
| Area under the curve extrapolated to infinity (AUC0-∞). | Day 2 (Periods 1 and 2) and Day 6 (Period 3) | |
| Percent of AUC0-inf extrapolated (AUC%extrap) | Day 2 (Periods 1 and 2) and Day 6 (Period 3) | |
| Maximum plasma concentration (Cmax). | Day 2 (Periods 1 and 2) and Day 6 (Period 3) | |
| Time to the maximum plasma concentration (Tmax). | Day 2 (Periods 1 and 2) and Day 6 (Period 3) | |
| Terminal elimination half-life (t½). | Day 2 (Periods 1 and 2) and Day 6 (Period 3) | |
| Apparent total body clearance (CL/F) | Day 2 (Periods 1 and 2) and Day 6 (Period 3) | |
| Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vz/F). | Day 2 (Periods 1 and 2) and Day 6 (Period 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent AEs (including SAEs) categorized by severity and relationship to study drug. | ECG, Clinical Laboratories, Vitals Signs and Physical Exams will be used as a safety measure to detect any AEs. | 12 to 14 days after the last dose of study drug |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Melnick, M.D. | Spero Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Facility | Phoenix | Arizona | 85283 | United States |
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|
| 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 |
|
| ID | Term |
|---|---|
| C500135 | tebipenem |
| D000536 | Aluminum Hydroxide |
| D008276 | Magnesium Hydroxide |
| D012841 | Simethicone |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D017607 | Aluminum Compounds |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D017616 | Magnesium Compounds |
| D004129 | Dimethylpolysiloxanes |
| D012828 | Silicones |
| D012833 | Siloxanes |
| D017646 | Organosilicon Compounds |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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