Clinical Trials Logo
  1. Home
  2. Urinary Tract Infections
  3. NCT05760261

Drug Interaction Assessment of GSK3882347 in Healthy Participants Aged 18 to 65 Years

Urinary Tract Infections Clinical Trial

Official title:
A Phase 1, Open-Label Study in Healthy Participants Aged 18 to 65 Years to Investigate the CYP3A4 Induction Potential of GSK3882347

Clinical Trial Summary

The objective of this study is to determine the magnitude and clinical relevance of a potential drug-drug interaction of GSK3882347 with midazolam (MDZ) in healthy participants. This study assesses the effect of GSK3882347 as an inducer of Cytochrome P450 3A4 (CYP3A4) using MDZ, a sensitive substrate of hepatic and intestinal CYP3A4. The study will investigate MDZ pharmacokinetic (PK) effect in two dosing periods: Period 1: A single dose of MDZ Period 2: 14-days of once daily repeat dosing of GSK3882347 followed by single dose of MDZ co-administered with GSK3882347 on Day 15 (14-days has been selected as this duration is required in order to maximize any potential CYP3A4 enzyme induction).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05760261
Study type Interventional
Source GlaxoSmithKline
Contact
Status Suspended
Phase Phase 1
Start date March 6, 2023
Completion date August 1, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04495699 - Asymptomatic Renal Calculi in Recurrent Urinary Tract Infections
Terminated NCT05254808 - EXtended Use of FOsfomycin for the Treatment of CYstitis in Primary Care Phase 3
Completed NCT03680612 - Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI Phase 2
Completed NCT03282006 - Treating Pyelonephritis an Urosepsis With Pivmecillinam Phase 4
Completed NCT03526484 - The Utility of Urinalysis Prior to In-Office Procedures N/A
Completed NCT05397782 - Effects of Flourish on Recurrent Urinary Tract Infection N/A
Completed NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03687255 - Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections Phase 3
Recruiting NCT05227937 - Single Dose Amikacin for Uncomplicated Cystitis in the ED: A Feasibility Study
Completed NCT02864420 - Hospitalization at Home: The Acute Care Home Hospital Program for Adults N/A
Completed NCT03131609 - Avoiding Bacterial Contamination of Clean Catch Urine Cultures in Ambulatory Patients in the Emergency Department
Completed NCT01911143 - A Retrospective, Blinded Validation of a Host-response Based Diagnostics N/A
Completed NCT01333254 - A Trial of Different Methods for Bladder Drainage in Hip Surgery Patients N/A
Terminated NCT00594594 - Adjuntive Probiotic Therapy in Treating Urinary Tract Infections in Spinal Cord Injury Phase 1
Completed NCT00216853 - A Study of Vaginal MicroFlora and Immune Profiles of Patients With Recurrent Urinary Tract Infection N/A
Completed NCT00787085 - The Significance of Funguria in Hospitalized Patients N/A
Completed NCT05719753 - The Effectiveness of a Bacteriophobic Coating on Urinary Catheters N/A
Recruiting NCT05415865 - The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder Phase 3
Not yet recruiting NCT05880329 - DIagnoSing Care hOme UTI Study
Recruiting NCT04615065 - Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine