Clinical Trials Logo
NCT number NCT03303924
Study type Interventional
Source Entasis Therapeutics
Status Completed
Phase Phase 1
Start date August 21, 2017
Completion date October 26, 2017

Clinical Trial Summary

This is a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult male and female subjects to determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of ETX2514 and sulbactam in healthy adult subjects after intravenous infusion of ETX2514 1.0 g given concurrently with intravenous sulbactam 1.0 g, administered every 6 hours with each infused over 3 hours, for 3 consecutive doses

Clinical Trial Description

Blood samples for determining plasma concentrations of ETX2514 and sulbactam will be collected within 5 minutes prior to and at 1.0, 2.0, 2.5, 2.95, 3.05, 3.25, 3.5, 4.0, 5.0 and 6.0 hours after start of the third dose (last dose) administered on Day 2.

Each subject will undergo one standardized bronchoscopy with bronchoalveolar lavage (BAL) in the outpatient bronchoscopy suite at 1.0, 2.5, 3.25, 4.0, or 6.0 hours after start of the infusion of the third dose of ETX2514 and sulbactam (6 subjects per timepoint) on Day 2.

Safety will be assessed throughout the study by adverse event monitoring, clinical laboratory tests, ECG, physical examination, and vital sign monitoring.

Study Design

Related Conditions & MeSH terms

See also
  Status Clinical Trial Phase
Terminated NCT00001844 - Study of New Magnetic Resonance Methods N/A
Enrolling by invitation NCT03160261 - Effect of Exenatide on Cortisol Secretion Phase 4
Recruiting NCT03203824 - The Effects of Dark Chocolate (70% Cacao) on EEG Brain Waves in Vigorously Active Individuals N/A
Recruiting NCT03056846 - Probiotics on Stress-associated Gastrointestinal Function in University Students N/A
Recruiting NCT03224702 - First-in-Human Trial of Anti-ADAMTS-5 Nanobody in Healthy Volunteers Phase 1
Recruiting NCT03259464 - This Study Tests BI 685509 in Healthy Chinese and Japanese Men; the Study Tests How Different Doses of BI 685509 Are Taken up in the Body and How Well They Are Tolerated Phase 1
Recruiting NCT03114839 - Effect of Lactobacillus Casei Shirota on the Small Intestinal Microbiota (ROBIN) N/A
Completed NCT03309566 - Bioequivalence Study of Two Formulatiosns With the Asscociaton of Efavirenz, Emtricitabine and Tenofovir Phase 4
Completed NCT00527579 - PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [F-18]FB Phase 1
Completed NCT00526916 - PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [C-11]PBR28 Phase 1
Recruiting NCT03277612 - Effects of C-section Delivery on Infant Brain Development N/A
Recruiting NCT02509494 - Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo During Implementation of Stages 1 and 2 Phase 3
Terminated NCT02555085 - Single Ascending Doses of BIIB063 in Healthy Volunteers Phase 1
Completed NCT03125018 - Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (LNCS ADTX) N/A
Completed NCT03124901 - Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor N/A
Completed NCT00004556 - The Effects of Dextroamphetamine on Brain Function N/A
Completed NCT00091533 - Neural Correlates of Observation of Tactile Stimulation in Healthy Subjects N/A
Completed NCT00068926 - VRC 300: Screening of Healthy Volunteers for Clinical Trials of Investigational Vaccines to Prevent Infectious Diseases N/A
Recruiting NCT03280173 - A Study Comparing the Amounts of 2 Different Forms of Tafamidis (PF06291826), Both With and Without Food, In the Blood Phase 1
Completed NCT02947139 - Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers Phase 1