Urinary Tract InfectionsPhase 1NCT05760261
Drug Interaction Assessment of GSK3882347 in Healthy Participants Aged 18 to 65 Years
A Phase 1 study testing Midazolam and GSK3882347 in people with Urinary Tract Infections, run by GlaxoSmithKline at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Midazolam and GSK3882347
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Apr 2023to 20 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. A participant with a clinical abnormality or laboratory parameter(s) not specifically listed in the exclusion or exclusion criteria that is outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor (if required), agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Body weight at least 50.0 kilogram (kg) (110 pound [lbs.]) for males and 45.0 kg (99 lbs.) for females; and body mass index (BMI) within the range 18.5 - 32.0 kg per meter square (kg/m^2) (inclusive).
- 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:
- Refrain from donating fresh unwashed semen
- Plus, either:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
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- OR
- Must agree to use contraception/barrier.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
- Is a woman of non-childbearing potential (WONCBP) . OR
- Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of lesser than (<) 1 percent (%).
- A WOCBP must have a negative highly sensitive pregnancy test [urine or serum] as required by local regulations) within 24h before the first dose of study intervention.
- The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
Who cannot join
- History or presence of significant cardiovascular, respiratory, hepatic, renal, urological, gastrointestinal, metabolic, endocrinological, hematological, immunologic, dermatologic, neurological or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data or in the opinion of the investigator places the participants at unacceptable risk or would make adhering to study procedures for the duration of the study difficult. Participants who have had a gastric bypass or a cholecystectomy are excluded from the study.
- Abnormal blood pressure, as determined by the investigator.
- Alanine transferase (ALT) value greater than (>)1.5 × upper limit of normal (ULN).
- Bilirubin value >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- The participant has a current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- The participant has congenital long QT syndrome or known prolongation of the corrected QT (QTc) interval.
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- The participant has any history of heart failure.
- The participant has a family history of QT prolongation or sudden death.
- The participant has any current or previous a history of episodes of symptomatic bradycardia or bradyarrhythmia.
- 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).
- The participant must agree to and adhere to the concomitant therapy (including nondrug therapies) restrictions from the Screening Visit through to the end of the end of the study (including telephone visit).
- Participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 56 days.
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
- Current enrolment or past participation within the last 30 days or 5 half-lives, whichever is longer, before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research.
- Current enrolment or past participation in this clinical study.
- Positive human immunodeficiency virus (HIV) antibody test.
- Presence of Hepatitis B surface antigen (HbsAg) at screening or within 3 months prior to first dose of study intervention.
- Hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
- A positive confirmation of Coronavirus disease 2019 (COVID-19) infection, or high clinical index of suspicion for COVID-19.
- The participant, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete the study.
- Regular alcohol consumption within 6 months prior to the study. An average weekly intake of >14 units for males or females. One unit is equivalent to approximately to 8 g of alcohol: a half-pint (approximately [~]240 mL) of beer, one glass (125 mL) of wine or one (25 mL) measure of spirits.
- Positive smoke breathalyzer indicative of smoking history at screening and each in-house admission to the clinical research unit or regular use of tobacco or nicotine-containing products (i.e., nicotine patches or vaporizing devices) within 3 months prior to screening.
- Regular use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to "vape".
- Any history of substance abuse or a positive urine test for drugs of abuse/ alcohol breath screen at screening or admission.
- Known hypersensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
- Contraindication for MDZ (i.e., Hypersensitivity to the active substance, benzodiazepines or to any of the excipients, myasthenia gravis, respiratory insufficiency, sleep apnea syndrome, severe hepatic impairment).
- Use of any products intended to treat medical conditions that are not approved by the governing health authority in a given country or region (for example, herbal medicine, health supplements, traditional medicine, homeopathic remedies, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study in Healthy Participants Aged 18 to 65 Years to Investigate the CYP3A4 Induction Potential of GSK3882347
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).
- Conditions
- Urinary Tract Infections
- Being tested
- Midazolam, GSK3882347
- Keywords
- Drug-drug interaction, Cytochrome P450 3A4 (CYP3A4), 1-hydroxymidazolam, Hormonal contraceptive agent
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Midazolam will be administered.
GSK3882347Drug
GSK3882347 will be administered.
| Study group | Role | What they receive |
|---|---|---|
| GSK3882347 and MDZ | Experimental | 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. Receives: Drug: Midazolam; Drug: GSK3882347 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Period 1: Area under the curve from time zero to 24 hours (AUC [0-24]) for plasma concentration of MDZ
Measured: Up to 24 hours
Period 1: AUC (0-24) for plasma concentration of 1-hydroxy-MDZ
Measured: Up to 24 hours
Period 2: AUC (0-24) for plasma concentration of MDZ
Measured: Up to 24 hours
Period 2: AUC (0-24) for plasma concentration of 1-hydroxy-MDZ
Measured: Up to 24 hours
Period 1: AUC from time zero to last time of quantifiable concentration (AUC [0-tau]) for plasma concentration of MDZ
Measured: Up to Day 2
Period 1: AUC (0-tau) for plasma concentration of 1-hydroxy-MDZ
Measured: Up to Day 2
Period 2: AUC (0-tau) for plasma concentration of MDZ
Measured: Up to Day 15
Period 2: AUC (0-tau) for plasma concentration of 1-hydroxy-MDZ
Measured: Up to Day 15
Period 1: AUC from time zero extrapolated to infinite time (AUC [0-inf]) for plasma concentration of MDZ
Measured: Up to Day 2
Period 1: AUC (0-inf) for plasma concentration of 1-hydroxy-MDZ
Measured: Up to Day 2
Period 2: AUC (0-inf) for plasma concentration of MDZ
Measured: Up to Day 15
Period 2: AUC (0-inf) for plasma concentration of 1-hydroxy-MDZ
Measured: Up to Day 15
Period 1: Maximum plasma concentration (Cmax) of MDZ
Measured: Up to Day 2
Period 1: Cmax of 1-hydroxy-MDZ
Measured: Up to Day 2
Period 2: Cmax of MDZ
Measured: Up to Day 15
Period 2: Cmax of 1-hydroxy-MDZ
Measured: Up to Day 15
Period 1: Time to Cmax (Tmax) of MDZ
Measured: Up to Day 2
Period 1: Tmax of 1-hydroxy-MDZ
Measured: Up to Day 2
Period 2: Tmax of MDZ
Measured: Up to Day 15
Period 2: Tmax of 1-hydroxy-MDZ
Measured: Up to Day 15
Period 1: Time lag before observation of measurable concentrations (Tlag) of MDZ
Measured: Up to Day 2
Period 1: Tlag of 1-hydroxy-MDZ
Measured: Up to Day 2
Period 2: Tlag of MDZ
Measured: Up to Day 15
Period 2: Tlag of 1-hydroxy-MDZ
Measured: Up to Day 15
Period 1: Time to half-life (T1/2) of MDZ
Measured: Up to Day 2
Period 1: T1/2 of 1-hydroxy-MDZ
Measured: Up to Day 2
Period 2: T1/2 of MDZ
Measured: Up to Day 15
Period 2: T1/2 of 1-hydroxy-MDZ
Measured: Up to Day 15
Secondary outcomes (19)
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to Day 15
Number of participants with clinically significant changes in hematology laboratory values
Measured: Up to Day 15
Number of participants with clinically significant changes in chemistry laboratory values
Measured: Up to Day 15
Number of participants with clinically significant changes in urinalysis laboratory values
Measured: Up to Day 15
Number of participants with clinically significant changes in vital sign values
Measured: Up to Day 15
Number of participants with clinically significant changes in 12-lead electrocardiogram (ECG) readings
Measured: Up to Day 15
AUC (0-24) for plasma concentration of GSK3882347
Measured: Up to 24 hours
Plasma concentrations over the dosing interval tau (Ctau) of GSK3882347
Measured: Up to Day 15
Oral clearance (CL/F) of GSK3882347
Measured: Up to Day 15
Volume of distribution/ Bioavailability (Vd/F) of GSK3882347
Measured: Up to Day 15
Mean residence time (MRT) of GSK3882347
Measured: Up to Day 15
AUC(0-inf) for single dose of GSK3882347
Measured: Up to Day 2
Cmax for single dose of GSK3882347
Measured: Up to Day 2
AUC(0-tau) for repeat dose of GSK3882347
Measured: Up to Day 15
Cmax for repeat dose of GSK3882347
Measured: Up to Day 15
Accumulation ratio (Ro) using AUC (0-tau) for repeat dose of GSK3882347
Measured: Up to Day 15
Time invariance using AUC(0-tau) (repeat dose) of GSK3882347
Measured: Up to Day 15
Time invariance using AUC(0-inf) (single dose) of GSK3882347
Measured: Up to Day 2
Achievement of steady state of GSK3882347
Measured: Up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start11 Apr 2023
- Primary completion13 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760261
- Sponsor's protocol ID
- 213252
- Status last verified
- Jan 2025
- First submitted
- 27 Feb 2023
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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/
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study in Healthy Participants Aged 18 to 65 Years to Investigate the CYP3A4 Induction Potential of GSK3882347
- ClinicalTrials.gov ID
- NCT05760261
- Acronym / sponsor ID
- 213252
- Conditions
- Urinary Tract Infections
- Keywords
- Drug-drug interaction, Cytochrome P450 3A4 (CYP3A4), 1-hydroxymidazolam, Hormonal contraceptive agent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSK3882347 and MDZ | Experimental | Drug: Midazolam, Drug: GSK3882347Period 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. A participant with a clinical abnormality or laboratory parameter(s) not specifically listed in the exclusion or exclusion criteria that is outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor (if required), agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Body weight at least 50.0 kilogram (kg) (110 pound [lbs.]) for males and 45.0 kg (99 lbs.) for females; and body mass index (BMI) within the range 18.5 - 32.0 kg per meter square (kg/m^2) (inclusive).
- 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:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
- OR
Key exclusion criteria (28 listed)
- History or presence of significant cardiovascular, respiratory, hepatic, renal, urological, gastrointestinal, metabolic, endocrinological, hematological, immunologic, dermatologic, neurological or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data or in the opinion of the investigator places the participants at unacceptable risk or would make adhering to study procedures for the duration of the study difficult. Participants who have had a gastric bypass or a cholecystectomy are excluded from the study.
- Abnormal blood pressure, as determined by the investigator.
- Alanine transferase (ALT) value greater than (>)1.5 × upper limit of normal (ULN).
- Bilirubin value >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- The participant has a current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamMidazolam will be administered. | Drug | GSK3882347 and MDZ |
| GSK3882347GSK3882347 will be administered. | Drug | GSK3882347 and MDZ |
Primary outcome
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
19 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Midazolam and GSK3882347 in people with Urinary Tract Infections, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.