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

NCT06597500 | Completed Phase 1

• 1 other identifier: 218376
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

GSK3923868; Itraconazole; Pharmacokinetics; Drug interaction; Phosphatidylinositol 4-kinase beta (PI4KB)

Outcome Measures

Primary Outcomes (8)

• 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

  Up to Day 3

• Treatment Period 2: AUC(0-t) for GSK3923868 with itraconazole co-administration

  Up to Day 11

• Treatment Period 1: AUC from time zero to infinity [AUC(0-∞)] for GSK3923868 without itraconazole co-administration

  Up to Day 3

• Treatment Period 2: AUC(0-∞) for GSK3923868 with itraconazole co-administration

  Up to Day 11

• Treatment Period 1: Maximum observed plasma concentration (Cmax) for GSK3923868 without itraconazole co-administration

  Up to Day 3

• Treatment Period 2: Cmax for GSK3923868 with itraconazole co-administration

  Up to Day 11

• Treatment Period 1: Time to Cmax (Tmax) for GSK3923868 without itraconazole co-administration

  Up to Day 3

• Treatment Period 2: Tmax for GSK3923868 with itraconazole co-administration

  Up to Day 11

Secondary Outcomes (9)

• Number of participants with adverse events (AEs)

  Up to Day 30

• Number of participants with serious adverse events (SAEs)

  Up to Day 30

• Number of participants with clinically significant changes in laboratory values

  Up to Day 30

• Number of participants with clinically significant changes in vital signs

  Up to Day 30

• Number of participants with clinically significant changes in 12-lead electrocardiogram (ECG) measurements

  Up to Day 30

Study Arms (2)

Treatment Period 1: GSK3923868

EXPERIMENTAL

Participants will receive GSK3923868 on Day 1.

Drug: GSK3923868

Treatment Period 2: GSK3923868 + Itraconazole

EXPERIMENTAL

Participants will receive itraconazole from Days 1 to 10 and GSK3923868 on Day 5.

Drug: GSK3923868; Drug: Itraconazole

Interventions

GSK3923868 DRUG

GSK3923868 will be administered.

Treatment Period 1: GSK3923868; Treatment Period 2: GSK3923868 + Itraconazole

Itraconazole DRUG

Itraconazole will be administered.

Treatment Period 2: GSK3923868 + Itraconazole

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Cambridge, CB2 0GG, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Click here to enter text.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: September 30, 2024
• Primary Completion: December 16, 2024
• Study Completion: December 23, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

GB (1)