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TBP-PI-HBr · 3 trials · 4 indications
Overall response includes combined clinical cure plus microbiological eradication. Clinical cure is defined as a complete resolution or significant improvement of signs and symptoms of cUTI or AP present at baseline and no new symptoms, such that no further antibacterial therapy is warranted, and participant is alive. Microbiological eradication (favorable microbiological response) is defined as a reduction of baseline uropathogens to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline and participant is alive.
| Arm | Type | Description |
|---|---|---|
| TBP-PI-HBr | EXPERIMENTAL | Participants received TBP-PI-HBr 600 milligrams (mg), two x 300mg film-coated tablets, orally (PO) and a dummy infusion intravenously (IV), every 6 hours (q6h) from Day 1 through Day 10. Participants with estimated baseline creatinine clearance (CrCl) greater than (\>) 30 millilitres per minute (mL/min) and less than or equal to (≤) 50 mL/min received TBP-PI-HBr 300 mg q6h. |
| Imipenem-cilastatin | ACTIVE_COMPARATOR | Participants received imipenem-cilastatin 500 mg, IV and matched dummy tablets, PO, q6h from Day 1 through Day 10. Dose adjustments for imipenem-cilastatin were made for participants with estimated baseline CrCl less than (\<) 90mL/min per approved imipenem-cilastatin package insert. Participants with baseline CrCl levels greater than or equal to (≥) 60 to \< 90 mL/min were administered imipenem-cilastatin, 400 mg IV q6h and participants with baseline CrCl levels \>30 to \<60 mL/min, were administered 300mg IV, q6h. |
| Part A: Cohort 1 | EXPERIMENTAL | Participants will receive TBP-PI-HBr, 900 milligrams (mg) tablets orally, as a single dose under fasted condition on Day 1. |
| Part A: Cohort 2 (Fasted/Fed) | EXPERIMENTAL | Participants will receive TBP-PI-HBr, 1200 mg, tablets, orally, as a single dose under fasted and fed conditions on Day 1 and Day 3, as per the assigned crossover sequence. |
| Part B: Cohort 3 | EXPERIMENTAL | Participants will receive TBP-PI-HBr, 600 mg, orally as a single dose on Day 1, followed by 9 doses every 6 hours from Day 3 through Day 5. (first and ninth dose will be given under fasted conditions). |
| TBP-PI-HBr 600 mg | EXPERIMENTAL | Healthy participants meeting eligibility criteria will receive a single oral dose of TBP-PI-HBr 600 mg tablets (2 x 300 mg) on Day 1 under fasted conditions. |
| Name | Type | Description |
|---|---|---|
| TBP-PI-HBr | DRUG | TBP-PI-HBr film-coated immediate-release tablets. |
| Imipenem-cilastatin | DRUG | Sterile powder for reconstitution administered as IV. |
| Dummy Infusion | DRUG | 0.9% sodium chloride administered as IV infusion. |
| Dummy Tablets | DRUG | TBP-PI-HBr matching dummy tablets. |
Inclusion Criteria: 1. Have a diagnosis of cUTI or AP. 2. Have an adequate urine specimen for evaluation and culture obtained within 24 hours prior to randomization with evidence of pyuria that includes at least one of the following: 1. at least 10 white blood cells (WBCs) per high power field ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 2 | PHASE1 | Gepotidacin |
| CorMedix Inc. | CRMD | 1 | PHASE2 | Meropenem-Vaborbactam, Antibiotics |
| Pfizer Inc. | PFE | 1 | - | Undisclosed |
| QIAGEN NV | QGEN | 1 | - | Undisclosed |