Clinical Trials - SPRO

NCT IDTitleStatusPhasesStart DateCompletion DatePrimary Completion Date
NCT06727136A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its Major Metabolite (SPR1349) in Healthy ParticipantsCOMPLETEDPHASE12024-11-202025-04-222025-04-22
NCT06059846A 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)COMPLETEDPHASE32023-12-212025-02-062025-01-18
NCT05966688A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy ParticipantsCOMPLETEDPHASE12023-08-042024-02-042024-01-30
NCT05955586A 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.COMPLETEDPHASE12023-08-012024-02-232024-02-09
NCT05856747A Study to Compare Two Bioanalytical Assays for TebipenemCOMPLETEDPHASE12023-05-042023-06-012023-06-01
NCT05496374A 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 DiseaseCOMPLETEDPHASE22022-12-142024-12-022024-10-08
NCT04865393Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal FunctionCOMPLETEDPHASE12021-06-082021-12-062021-12-01
NCT04868292Study to Assess the Intrapulmonary Pharmacokinetics of SPR206 in Healthy VolunteersCOMPLETEDPHASE12021-06-032021-09-292021-09-16
NCT04710407Study 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 VolunteersCOMPLETEDPHASE12020-12-072021-03-102021-03-10
NCT04553406Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary DiseaseTERMINATEDPHASE22020-12-032021-01-282021-01-28
NCT04625855Study of the Absorption, Metabolism, and Excretion of [14C]-Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) Following a Single Oral Dose in Healthy Male SubjectsCOMPLETEDPHASE12020-09-302020-10-162020-10-16
NCT04368585Study to Examine the Effect of Antacid and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult SubjectsCOMPLETEDPHASE12020-07-012020-08-212020-08-08
NCT04421885Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult SubjectsCOMPLETEDPHASE12020-06-012020-07-292020-07-11
NCT04376554Effect of Tebipenem on Normal Human Intestinal MicrobiotaCOMPLETEDPHASE12020-02-102021-04-062021-04-06
NCT04238195A 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 SubjectsCOMPLETEDPHASE12020-01-192020-02-262020-02-26
NCT04178577Phase 1 Study of PK and Safety of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Subjects With Various Degrees Of Renal FunctionCOMPLETEDPHASE12019-12-062020-09-112020-09-06
NCT03788967Study 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)COMPLETEDPHASE32019-06-032020-05-272020-05-20
NCT03792308A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR206 in Healthy VolunteersCOMPLETEDPHASE12018-12-182019-12-232019-12-23
NCT03796910A Study of the Safety, Tolerability, and Pharmacokinetics of SPR720 in Healthy VolunteersCOMPLETEDPHASE12018-12-182019-09-242019-09-24
NCT03376529Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741COMPLETEDPHASE12017-11-102017-12-202017-12-19
NCT03395249Phase 1 Study of Safety, Tolerability and Pharmacokinetics of SPR994COMPLETEDPHASE12017-10-202018-08-022018-08-02
NCT03022175A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR741 in Healthy VolunteersCOMPLETEDPHASE12016-122017-092017-07