TBPM-PI-HBr: Clinical Trials

6 completed. 5 Phase 1, 1 Phase 3.

By phase and status

Phase	Trials	Status
Phase 1	5	Completed 5
Phase 3	1	Completed 1

Follow TBPM-PI-HBr: new trials by email Literature Review of TBPM-PI-HBr trials Research Report on TBPM-PI-HBr

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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
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	Spero Therapeutics	30	2020-12-07	2021-03-16
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	Spero Therapeutics	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	Spero Therapeutics	20	2020-07-01	2020-09-04
Effect of Tebipenem on Normal Human Intestinal Microbiota TBPM-PI-HBr, amoxicillin-clavulanate - Healthy Volunteers	Phase 1	Completed	Spero Therapeutics	30	2020-02-10	2021-05-04
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	Spero Therapeutics	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	Spero Therapeutics	1372	2019-06-03	2022-07-25

Conditions studied

Kidney Diseases (1)  ·  Renal Insufficiency (1)

Sponsors

Spero Therapeutics (6)

Countries

United States (5)  ·  Bulgaria (1)  ·  Czechia (1)  ·  Estonia (1)  ·  Georgia (1)  ·  Hungary (1)  ·  Latvia (1)  ·  Moldova (1)  ·  Poland (1)  ·  Romania (1)  ·  Russia (1)  ·  Serbia (1)  ·  Slovakia (1)  ·  South Africa (1)  ·  Sweden (1)

Top investigators

David Melnick, M.D. (2)  ·  David Baratz, MD (1)  ·  David Melnick, MD (1)  ·  Irene Mirkin, MD (1)  ·  Steffan Rosenborg (1)

Results publications

PMID 35388666, PMID 35420493, PMID 35762796, PMID 38432233

NIH funding

2018 (1)