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

Korábbi kezelés

• 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.
• 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).
• Presence of hepatitis B surface antigen (HBsAg) within 3 months prior to first dose of study intervention.
• Positive hepatitis C ribonucleic acid (RNA) test result within 3 months prior to first dose of study intervention.
• Positive pre study drug/alcohol screen.
• 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.

Más betegség

• 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.
• Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• Positive hepatitis C antibody test result at screening.
• Positive human immunodeficiency virus (HIV) antibody test.
• Current or history of drug abuse.
• 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.

Laborértékek

• 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 [%]).
• 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.

Egyéb

• 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.
• Forced expiratory volume in 1 second (FEV1) < 80% predicted normal value.
• Positive breath carbon monoxide test indicative of recent smoking at screening or each in house admission to the clinical research unit.

• 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.