Pulmonary Disease, Chronic ObstructivePhase 1NCT06597500

A Study to Evaluate the Effect of Itraconazole on the Concentration of GSK3923868 in the Blood in Healthy Participants

A Phase 1 study testing GSK3923868 and Itraconazole in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate how itraconazole affects the blood concentration of GSK3923868 in healthy adults. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: GSK3923868 and Itraconazole
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited Kingdom
Study dates: 30 Sep 2024to 23 Dec 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 based on screening medical history, physical examination, vital signs, electrocardiogram (ECG) assessment, pulmonary function testing and laboratory tests.
Body weight at least 50 kilograms (kg) and body-mass index (BMI) within the range 18.5 to 32.0 kilogram per meter squared (kg/m^2) (inclusive).
For female participants: A female participant is eligible to participate if the participant is a woman of non-childbearing potential (WONCBP).
Capable of giving signed informed consent.

Who cannot join

History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological 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.
Alanine transaminase (ALT) and aspartate aminotransferase (AST) greater than (>) upper limit of normal (ULN).
Total bilirubin > ULN (isolated bilirubin above ULN is acceptable if total bilirubin is fractionated and direct bilirubin less than (<) 35 percentage [%]).
Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
QT interval corrected for heart rate according to Frederica's formula (QTcF) > 450 milliseconds (msec) at screening visit based on the average of triplicate ECGs.
Past or intended use of over the counter or prescription medication, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half lives (whichever is longer) before the first dose of study treatment, unless in the opinion of the Investigator and the GSK Medical Monitor, the medication will not interfere with the study procedures or compromise participant safety.

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Recent donation of blood or blood products such that participation in this study would result in loss of blood in excess of 500 milliliters (mL) within a 56 day period.
Exposure to more than 4 new chemical entities within 12 months before the first dosing day.
Current enrolment or past participation in a clinical trial and has received an investigational product within the following time period before the first dosing day in this study: 30 days, 5 half lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Forced expiratory volume in 1 second (FEV1) < 80% predicted normal value.
Presence of hepatitis B surface antigen (HBsAg) within 3 months prior to first dose of study intervention.
Positive hepatitis C antibody test result at screening.
Positive hepatitis C ribonucleic acid (RNA) test result within 3 months prior to first dose of study intervention.
Positive pre study drug/alcohol screen.
Positive human immunodeficiency virus (HIV) antibody test.
Current or history of drug abuse.
History of regular alcohol consumption within 6 months prior to the study defined as an average weekly intake of > 14 units for males and females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
Current or previous use of tobacco or nicotine containing products (e.g. cigarettes, nicotine patches or electronic devices) within 6 months before screening and/or have a smoking pack history of > 5 pack years.
Positive breath carbon monoxide test indicative of recent smoking at screening or each in house admission to the clinical research unit.
Sensitivity to the study interventions (GSK3923868, itraconazole or other azole antifungal agents) or components thereof, or drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates participation in the study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
Cambridge, CB2 0GG

Other trials in United Kingdom

About this study

Official title: A Single-Centre, Open-Label, Single Sequence Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Single Inhaled Doses of GSK3923868 in Healthy Participants

The purpose of this study is to evaluate how itraconazole affects the blood concentration of GSK3923868 in healthy adults.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: GSK3923868, Itraconazole
Keywords: GSK3923868, Itraconazole, Pharmacokinetics, Drug interaction, Phosphatidylinositol 4-kinase beta (PI4KB)
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK3923868Drug
GSK3923868 will be administered.
ItraconazoleDrug
Itraconazole will be administered.

Study groups in NCT06597500
Study group	Role	What they receive
Treatment Period 1: GSK3923868	Experimental	Participants will receive GSK3923868 on Day 1. Receives: Drug: GSK3923868
Treatment Period 2: GSK3923868 + Itraconazole	Experimental	Participants will receive itraconazole from Days 1 to 10 and GSK3923868 on Day 5. Receives: Drug: GSK3923868; Drug: Itraconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment Period 1: Area under plasma concentration versus time curve (AUC) from time zero to last quantifiable concentration [AUC(0-t)] for GSK3923868 without itraconazole co-administration
Measured: Up to Day 3
Treatment Period 2: AUC(0-t) for GSK3923868 with itraconazole co-administration
Measured: Up to Day 11
Treatment Period 1: AUC from time zero to infinity [AUC(0-∞)] for GSK3923868 without itraconazole co-administration
Measured: Up to Day 3
Treatment Period 2: AUC(0-∞) for GSK3923868 with itraconazole co-administration
Measured: Up to Day 11
Treatment Period 1: Maximum observed plasma concentration (Cmax) for GSK3923868 without itraconazole co-administration
Measured: Up to Day 3
Treatment Period 2: Cmax for GSK3923868 with itraconazole co-administration
Measured: Up to Day 11
Treatment Period 1: Time to Cmax (Tmax) for GSK3923868 without itraconazole co-administration
Measured: Up to Day 3
Treatment Period 2: Tmax for GSK3923868 with itraconazole co-administration
Measured: Up to Day 11

Secondary outcomes (9)

Number of participants with adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Measured: Up to Day 30
Number of participants with serious adverse events (SAEs)
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product.
Measured: Up to Day 30
Number of participants with clinically significant changes in laboratory values
Measured: Up to Day 30
Number of participants with clinically significant changes in vital signs
Measured: Up to Day 30
Number of participants with clinically significant changes in 12-lead electrocardiogram (ECG) measurements
Measured: Up to Day 30
Treatment Period 2: AUC(0-t) for itraconazole and hydroxy-itraconazole
Measured: On Days 1 and 5
Treatment Period 2: AUC(0-∞) for itraconazole and hydroxy-itraconazole
Measured: On Days 1 and 5
Treatment Period 2: Cmax for itraconazole and hydroxy-itraconazole
Measured: On Days 1 and 5
Treatment Period 2: Tmax for itraconazole and hydroxy-itraconazole
Measured: On Days 1 and 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 202423 Dec 2024

First posted19 Sep 2024
Study start30 Sep 2024
Primary completion16 Dec 2024
Study completion23 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06597500
Sponsor's protocol ID: 218376
Status last verified: Mar 2025
First submitted: 12 Sep 2024
Last updated: 7 Mar 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/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Centre, Open-Label, Single Sequence Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Single Inhaled Doses of GSK3923868 in Healthy Participants
ClinicalTrials.gov ID: NCT06597500
Acronym / sponsor ID: 218376
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: GSK3923868, Itraconazole, Pharmacokinetics, Drug interaction, Phosphatidylinositol 4-kinase beta (PI4KB)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 30 Sep 2024 (actual)
Primary completion: 16 Dec 2024 (actual)
Study completion: 23 Dec 2024 (actual)
First posted: 19 Sep 2024 (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 purpose of this study is to evaluate how itraconazole affects the blood concentration of GSK3923868 in healthy adults.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment Period 1: GSK3923868	Experimental	Drug: GSK3923868Participants will receive GSK3923868 on Day 1.
Treatment Period 2: GSK3923868 + Itraconazole	Experimental	Drug: GSK3923868, Drug: ItraconazoleParticipants will receive itraconazole from Days 1 to 10 and GSK3923868 on Day 5.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Participants who are overtly healthy as determined by medical evaluation based on screening medical history, physical examination, vital signs, electrocardiogram (ECG) assessment, pulmonary function testing and laboratory tests.
Body weight at least 50 kilograms (kg) and body-mass index (BMI) within the range 18.5 to 32.0 kilogram per meter squared (kg/m^2) (inclusive).
For female participants: A female participant is eligible to participate if the participant is a woman of non-childbearing potential (WONCBP).
Capable of giving signed informed consent.

Key exclusion criteria (20 listed)

History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological 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.
Alanine transaminase (ALT) and aspartate aminotransferase (AST) greater than (>) upper limit of normal (ULN).
Total bilirubin > ULN (isolated bilirubin above ULN is acceptable if total bilirubin is fractionated and direct bilirubin less than (<) 35 percentage [%]).
Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
QT interval corrected for heart rate according to Frederica's formula (QTcF) > 450 milliseconds (msec) at screening visit based on the average of triplicate ECGs.

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
GSK3923868GSK3923868 will be administered.	Drug	Treatment Period 1: GSK3923868, Treatment Period 2: GSK3923868 + Itraconazole
ItraconazoleItraconazole will be administered.	Drug	Treatment Period 2: GSK3923868 + Itraconazole

Primary outcome

Treatment Period 1: Area under plasma concentration versus time curve (AUC) from time zero to last quantifiable concentration [AUC(0-t)] for GSK3923868 without itraconazole co-administration
Time frame: Up to Day 3
Treatment Period 2: AUC(0-t) for GSK3923868 with itraconazole co-administration
Time frame: Up to Day 11
Treatment Period 1: AUC from time zero to infinity [AUC(0-∞)] for GSK3923868 without itraconazole co-administration
Time frame: Up to Day 3
Treatment Period 2: AUC(0-∞) for GSK3923868 with itraconazole co-administration
Time frame: Up to Day 11
Treatment Period 1: Maximum observed plasma concentration (Cmax) for GSK3923868 without itraconazole co-administration
Time frame: Up to Day 3
Treatment Period 2: Cmax for GSK3923868 with itraconazole co-administration
Time frame: Up to Day 11
Treatment Period 1: Time to Cmax (Tmax) for GSK3923868 without itraconazole co-administration
Time frame: Up to Day 3
Treatment Period 2: Tmax for GSK3923868 with itraconazole co-administration
Time frame: Up to Day 11

9 secondary outcomes

Number of participants with adverse events (AEs)
Time frame: Up to Day 30
Number of participants with serious adverse events (SAEs)
Time frame: Up to Day 30
Number of participants with clinically significant changes in laboratory values
Time frame: Up to Day 30
Number of participants with clinically significant changes in vital signs
Time frame: Up to Day 30
Number of participants with clinically significant changes in 12-lead electrocardiogram (ECG) measurements
Time frame: Up to Day 30
Treatment Period 2: AUC(0-t) for itraconazole and hydroxy-itraconazole
Time frame: On Days 1 and 5
Treatment Period 2: AUC(0-∞) for itraconazole and hydroxy-itraconazole
Time frame: On Days 1 and 5
Treatment Period 2: Cmax for itraconazole and hydroxy-itraconazole
Time frame: On Days 1 and 5
Treatment Period 2: Tmax for itraconazole and hydroxy-itraconazole
Time frame: On Days 1 and 5

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 7 Mar 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/

Related trials for Pulmonary Disease, Chronic Obstructive

Active, not recruiting
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Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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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 GSK3923868 and Itraconazole in people with Pulmonary Disease, Chronic Obstructive, 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 4 inclusion and 20 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 7 Mar 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?

Treatment Period 1: Area under plasma concentration versus time curve (AUC) from time zero to last quantifiable concentration [AUC(0-t)] for GSK3923868 without itraconazole co-administration (time frame: Up to Day 3). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06597500.

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 7 Mar 2025.