23 completed, 1 terminated. 20 Phase 1, 2 Phase 2, 2 Phase 3.
By phase and status
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix .
Trial Phase Status Sponsor Enrollment Start Updated
A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its Major Metabolite (SPR1349) in Healthy Participants TBP-PI-HBr - Healthy Participants Phase 1 Completed 39 2024-11-20 2025-05-20 A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) TBP-PI-HBr, Imipenem-cilastatin, Dummy Infusion - Urinary Tract Infection, Acute Pyelonephritis Phase 3 Completed 1690 2023-12-21 2026-03-10 A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Participants SPR720, Azithromycin, Ethambutol - Healthy Volunteers Phase 1 Completed 39 2023-08-04 2024-03-04 A Study to Assess the Intrapulmonary Pharmacokinetics (PK) of SPR719 by Comparing the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations Following the Oral Administration of Multiple Doses of SPR720 in Healthy Volunteers. SPR720 - Healthy Volunteer Phase 1 Completed 33 2023-08-01 2024-03-07 A Study to Compare Two Bioanalytical Assays for Tebipenem TBP-PI-HBr - Healthy Volunteers Phase 1 Completed 20 2023-05-04 2024-03-27 A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Participants With Mycobacterium Avium Complex (MAC) Pulmonary Disease Placebo, SPR720 500 mg, SPR720 1000 mg - Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD) Phase 2 Completed 25 2022-12-14 2025-10-09 Bioavailability of Tebipenem (SPR994) Crushed Tablet Tebipenem tablet form, Tube feeds - Relative Bioavailability Phase 1 Completed 12 2022-04-01 2024-02-28 Tebipenem (SPR994) Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis Tebipenem Pivoxil Hydrobromide - Diabetes, Wound Infection Phase 1 Completed 12 2021-07-01 2023-10-23 Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal Function SPR206 - Renal Impairment Phase 1 Completed 37 2021-06-08 2024-04-15 Study to Assess the Intrapulmonary Pharmacokinetics of SPR206 in Healthy Volunteers SPR206 - Healthy Volunteers Phase 1 Completed 34 2021-06-03 2021-11-17 Study to Assess the Intrapulmonary Pharmacokinetics of SPR859 by Comparing the Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) Concentrations Following the Oral Administration of Five Doses of SPR994 in Healthy, Nonsmoking Volunteers TBPM-PI-HBr - Healthy Volunteers Phase 1 Completed 30 2020-12-07 2021-03-16 Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease SPR720, Placebo, Open-label Standard of Care - Mycobacterium Avium Complex, Non-tuberculous Mycobacterium Pulmonary Disease Phase 2 Terminated 2 2020-12-03 2022-02-28 Study of the Absorption, Metabolism, and Excretion of [14C]-Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) Following a Single Oral Dose in Healthy Male Subjects TBPM-PI-HBr - Healthy Volunteers Phase 1 Completed 8 2020-09-30 2020-11-12 Study to Examine the Effect of Antacid and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects Tebipenem pivoxil hydrobromide (TBPM-PI-HBr), 20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL), Omeprazole - Healthy Volunteers Phase 1 Completed 20 2020-07-01 2020-09-04 Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference, Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test - Healthy Volunteers Phase 1 Completed 36 2020-06-01 2020-08-12 Effect of Tebipenem on Normal Human Intestinal Microbiota TBPM-PI-HBr, amoxicillin-clavulanate - Healthy Volunteers Phase 1 Completed 30 2020-02-10 2021-05-04 A Single-Dose, Randomized, Placebo- and Active-Control, Four-Way, Cross-Over Study for the Evaluation of the Effect of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) on the QT/QTc Intervals in Adult Healthy Subjects Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) + Placebo, Moxifloxacin 400mg, Placebo for Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) - TQT Study Phase 1 Completed 24 2020-01-19 2020-03-13 Phase 1 Study of PK and Safety of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Subjects With Various Degrees Of Renal Function Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Renal Impairment Phase 1 Completed 39 2019-12-06 2020-11-27 Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) TBPM-PI-HBr, Ertapenem, Dummy Infusion - Complicated Urinary Tract Infection, Acute Pyelonephritis Phase 3 Completed 1372 2019-06-03 2022-07-25 A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR206 in Healthy Volunteers SPR206, Placebo - Healthy Volunteers Phase 1 Completed 94 2018-12-18 2020-01-10
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Conditions studied Kidney Diseases (2) · Mycobacterium avium-intracellulare Infection (2) · Renal Insufficiency (2) · Diabetes Mellitus (1) · Lung Diseases (1) · Urinary Tract Infections (1) · Wound Infection (1)
Interventions tebipenem (9) · Injections (2) · SPR741 (2) · Sodium Chloride (2) · Aluminum Hydroxide (1) · Amoxicillin-Potassium Clavulanate Combination (1) · Azithromycin (1) · Aztreonam (1) · Ceftazidime (1) · Cilastatin, Imipenem Drug Combination (1) · Ertapenem (1) · Ethambutol (1) · Magnesium Hydroxide (1) · Moxifloxacin (1) · Omeprazole (1)
Countries United States (16) · Australia (3) · United Kingdom (3) · Bulgaria (2) · Estonia (2) · Georgia (2) · Hungary (2) · Latvia (2) · Moldova (2) · Poland (2) · Romania (2) · Serbia (2) · Slovakia (2) · South Africa (2) · Argentina (1)
Top investigators David Melnick, MD (4) · Annelize Koch, MBChB (2) · David Melnick, M.D. (2) · Charlotte Lemech, FRACP, MD (1) · David Baratz, MD (1) · David Hong, MD (1) · David Melnick (1) · Irene Mirkin, MD (1) · James Kuo, MBBS, B Med Sci, FRACP (1) · Nicholas Farinola, MB, BSc, FRACP (1) · Steffan Rosenborg (1) · Tomefa E Asempa, PharmD (1) · Xilla Ussrey, MD (1)
Results publications PMID 31262767 , PMID 31262768 , PMID 34339267 , PMID 34491803 , PMID 35388666 , PMID 35420493 , PMID 35762796 , PMID 38432233 , PMID 39352135 , PMID 41720869
NIH funding 2018 (1) , 2023 (1)