NCT05760261 is a Phase 1 clinical trial of Midazolam in Urinary Tract Infections, sponsored by GlaxoSmithKline.

Who is sponsoring NCT05760261?

NCT05760261 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT05760261?

Interventions in NCT05760261: Midazolam, GSK3882347.

What condition does NCT05760261 study?

NCT05760261 studies Urinary Tract Infections.

Is NCT05760261 still recruiting?

NCT05760261 is currently completed. Last updated 16 January 2025.

Last reviewed 2025-01-16 · How we verify

NCT05760261

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 16 January 2025

What this trial tests

Phase 1 trial testing Midazolam in Urinary Tract Infections in 27 participants. Completed in 20 August 2024.

Timeline

11 April 2023

Primary endpoint
13 August 2024

20 August 2024

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	11 April 2023
Primary completion	13 August 2024
Estimated completion	20 August 2024
Sites	1 location across United Kingdom

Drugs / interventions tested

Midazolam (midazolam) — full drug profile →
GSK3882347 — full drug profile →

Conditions studied

Urinary Tract Infections — all drugs for Urinary Tract Infections →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Urinary Tract Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Midazolam

Trials testing the same drug.

NCT05945147 — Ketamine and Midazolam Infusions for CRPS: Feasibility Study · Phase 2 · withdrawn
NCT07525544 — A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants · Phase 1 · not yet recruiting
NCT07426757 — An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced Cancers · Phase 1 · not yet recruiting
NCT07435194 — A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazo · Phase 1 · recruiting
NCT07443254 — Prospective IR-led Sedation Feasibility · Phase 1, PHASE2 · recruiting

Other recruiting trials for Urinary Tract Infections

Currently open trials in the same condition.

NCT06976125 — Application of a Prediction Model for Directing Antibiotic Use in the Treatment of Urinary Tract Infection in an Ambulat · NA · recruiting
NCT06808451 — Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture · NA · recruiting
NCT07186465 — Microbiome-Modulating Prophylaxis RCT: Antibiotic vs Gynoflor in Postmenopausal Women With Recurrent Cystitis · Phase 4 · recruiting
NCT07207291 — Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers · Phase 1 · recruiting
NCT06715306 — Intravenous Versus Oral Treatment of the Main Acute Infections · NA · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05760261 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 16 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05760261.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing