A Phase 1 interventional study of Midazolam and GSK3882347 in Urinary Tract Infections, sponsored by GlaxoSmithKline. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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).
779 studies on the registry are indexed under Urinary Tract Infections; 132 are open to participants now.
This study's enrollment of 27 is below the median of 130 across 544 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Male participants are eligible to participate if they agree to the following during the study intervention Period and for at least 3 days, after the last dose of study intervention:
Plus, either:
OR
A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
Exclusion Criteria:
The participant has a QTc >450 millisecond (msec). Note: The QTc is the QT interval corrected for heart rate according to Fridericia formula, machine, or manual overread.
11. The participant has anuria, oliguria, or impairment of renal function (GFR by Modification of diet in renal disease [MDRD] \<90 milliliter per minute per 1.73 meter square [mL/min/1.73m\^2] or serum creatinine > ULN or urine albumin-creatinine ratio [ACR] of ≥300 milligram per gram [mg/g] at screening).
Period 1: Participants will receive MDZ on Day 1. Period 2: Participants will receive 14-days of repeat dosing of GSK3882347 Followed by one dose of MDZ co-administered with GSK3882347 on Day 15.
Drug: Midazolam · Drug: GSK3882347
Midazolam will be administered.
GSK3882347 will be administered.
Period 1: Area under the curve from time zero to 24 hours (AUC [0-24]) for plasma concentration of MDZ
Time frame: Up to 24 hours
Period 1: AUC (0-24) for plasma concentration of 1-hydroxy-MDZ
Time frame: Up to 24 hours
Period 2: AUC (0-24) for plasma concentration of MDZ
Time frame: Up to 24 hours
Period 2: AUC (0-24) for plasma concentration of 1-hydroxy-MDZ
Time frame: Up to 24 hours
Period 1: AUC from time zero to last time of quantifiable concentration (AUC [0-tau]) for plasma concentration of MDZ
Time frame: Up to Day 2
Period 1: AUC (0-tau) for plasma concentration of 1-hydroxy-MDZ
Time frame: Up to Day 2
Period 2: AUC (0-tau) for plasma concentration of MDZ
Time frame: Up to Day 15
Period 2: AUC (0-tau) for plasma concentration of 1-hydroxy-MDZ
Time frame: Up to Day 15
Period 1: AUC from time zero extrapolated to infinite time (AUC [0-inf]) for plasma concentration of MDZ
Time frame: Up to Day 2
Period 1: AUC (0-inf) for plasma concentration of 1-hydroxy-MDZ
Time frame: Up to Day 2
Period 2: AUC (0-inf) for plasma concentration of MDZ
Time frame: Up to Day 15
Period 2: AUC (0-inf) for plasma concentration of 1-hydroxy-MDZ
Time frame: Up to Day 15
Period 1: Maximum plasma concentration (Cmax) of MDZ
Time frame: Up to Day 2
Period 1: Cmax of 1-hydroxy-MDZ
Time frame: Up to Day 2
Period 2: Cmax of MDZ
Time frame: Up to Day 15
Period 2: Cmax of 1-hydroxy-MDZ
Time frame: Up to Day 15
Period 1: Time to Cmax (Tmax) of MDZ
Time frame: Up to Day 2
Period 1: Tmax of 1-hydroxy-MDZ
Time frame: Up to Day 2
Period 2: Tmax of MDZ
Time frame: Up to Day 15
Period 2: Tmax of 1-hydroxy-MDZ
Time frame: Up to Day 15
Period 1: Time lag before observation of measurable concentrations (Tlag) of MDZ
Time frame: Up to Day 2
Period 1: Tlag of 1-hydroxy-MDZ
Time frame: Up to Day 2
Period 2: Tlag of MDZ
Time frame: Up to Day 15
Period 2: Tlag of 1-hydroxy-MDZ
Time frame: Up to Day 15
Period 1: Time to half-life (T1/2) of MDZ
Time frame: Up to Day 2
Period 1: T1/2 of 1-hydroxy-MDZ
Time frame: Up to Day 2
Period 2: T1/2 of MDZ
Time frame: Up to Day 15
Period 2: T1/2 of 1-hydroxy-MDZ
Time frame: Up to Day 15
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to Day 15
Number of participants with clinically significant changes in hematology laboratory values
Time frame: Up to Day 15
Number of participants with clinically significant changes in chemistry laboratory values
Time frame: Up to Day 15
Number of participants with clinically significant changes in urinalysis laboratory values
Time frame: Up to Day 15
Number of participants with clinically significant changes in vital sign values
Time frame: Up to Day 15
Number of participants with clinically significant changes in 12-lead electrocardiogram (ECG) readings
Time frame: Up to Day 15
AUC (0-24) for plasma concentration of GSK3882347
Time frame: Up to 24 hours
Plasma concentrations over the dosing interval tau (Ctau) of GSK3882347
Time frame: Up to Day 15
Oral clearance (CL/F) of GSK3882347
Time frame: Up to Day 15
Volume of distribution/ Bioavailability (Vd/F) of GSK3882347
Time frame: Up to Day 15
Mean residence time (MRT) of GSK3882347
Time frame: Up to Day 15
AUC(0-inf) for single dose of GSK3882347
Time frame: Up to Day 2
Cmax for single dose of GSK3882347
Time frame: Up to Day 2
AUC(0-tau) for repeat dose of GSK3882347
Time frame: Up to Day 15
Cmax for repeat dose of GSK3882347
Time frame: Up to Day 15
Accumulation ratio (Ro) using AUC (0-tau) for repeat dose of GSK3882347
Time frame: Up to Day 15
Time invariance using AUC(0-tau) (repeat dose) of GSK3882347
Time frame: Up to Day 15
Time invariance using AUC(0-inf) (single dose) of GSK3882347
Time frame: Up to Day 2
Achievement of steady state of GSK3882347
Time frame: Up to Day 15
Plan to share: Yes — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Data sharing details ↗ · www.gsk.com
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: GSK3882347