NCT06597500已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
The purpose of this study is to evaluate how itraconazole affects the blood concentration of GSK3923868 in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment Period 2: GSK3923868 + Itraconazole
Experimental
Participants will receive itraconazole from Days 1 to 10 and GSK3923868 on Day 5.
干预措施: GSK3923868 (Drug)
Treatment Period 1: GSK3923868
Experimental
Participants will receive GSK3923868 on Day 1.
干预措施: GSK3923868 (Drug)
Treatment Period 2: GSK3923868 + Itraconazole
Experimental
Participants will receive itraconazole from Days 1 to 10 and GSK3923868 on Day 5.
干预措施: Itraconazole (Drug)
结局指标
主要结局
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
时间窗: Up to Day 3
Treatment Period 2: AUC(0-t) for GSK3923868 with itraconazole co-administration
时间窗: Up to Day 11
Treatment Period 1: AUC from time zero to infinity [AUC(0-∞)] for GSK3923868 without itraconazole co-administration
时间窗: Up to Day 3
Treatment Period 2: AUC(0-∞) for GSK3923868 with itraconazole co-administration
时间窗: Up to Day 11
Treatment Period 1: Maximum observed plasma concentration (Cmax) for GSK3923868 without itraconazole co-administration
时间窗: Up to Day 3
Treatment Period 2: Cmax for GSK3923868 with itraconazole co-administration
时间窗: Up to Day 11
Treatment Period 1: Time to Cmax (Tmax) for GSK3923868 without itraconazole co-administration
时间窗: Up to Day 3
Treatment Period 2: Tmax for GSK3923868 with itraconazole co-administration
时间窗: Up to Day 11
次要结局
- 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)
- Treatment Period 2: AUC(0-t) for itraconazole and hydroxy-itraconazole(On Days 1 and 5)
- Treatment Period 2: AUC(0-∞) for itraconazole and hydroxy-itraconazole(On Days 1 and 5)
- Treatment Period 2: Cmax for itraconazole and hydroxy-itraconazole(On Days 1 and 5)
- Treatment Period 2: Tmax for itraconazole and hydroxy-itraconazole(On Days 1 and 5)
研究者
研究点 (1)
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