Skip to main content
OpenTrials
Completed

NCT Number: NCT06597500

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Cambridge, CB2 0GG, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

GSK3923868

Drug

GSK3923868 will be administered.

Itraconazole

Drug

Itraconazole will be administered.

Primary outcomes

  1. 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

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

    Time frame: Up to Day 11

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

    Time frame: Up to Day 3

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

    Time frame: Up to Day 11

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

    Time frame: Up to Day 3

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

    Time frame: Up to Day 11

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

    Time frame: Up to Day 3

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

    Time frame: Up to Day 11

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to Day 30

    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.

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to Day 30

    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.

  3. Number of participants with clinically significant changes in laboratory values

    Time frame: Up to Day 30

  4. Number of participants with clinically significant changes in vital signs

    Time frame: Up to Day 30

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

    Time frame: Up to Day 30

  6. Treatment Period 2: AUC(0-t) for itraconazole and hydroxy-itraconazole

    Time frame: On Days 1 and 5

  7. Treatment Period 2: AUC(0-∞) for itraconazole and hydroxy-itraconazole

    Time frame: On Days 1 and 5

  8. Treatment Period 2: Cmax for itraconazole and hydroxy-itraconazole

    Time frame: On Days 1 and 5

  9. Treatment Period 2: Tmax for itraconazole and hydroxy-itraconazole

    Time frame: On Days 1 and 5

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.