NCT07636928招募中1 期
A Phase 1, Open-Label, Single Dose Study to Assess the Absolute Bioavailability, Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]VH4524184 in Healthy Participants
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 1
研究概览
简要总结
The purpose of the study is to assess the bioavailability, mass balance, pharmacokinetics, metabolism and excretion of radiolabeled (14C) VH4524184.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to sign the Informed Consent Form (ICF).
- •Sex at birth: male or female; female participants must be of non-childbearing potential, or postmenopausal.
- •Age: 18 to 55 years, inclusive, at screening.
- •BMI: 18.0 to 32.0 kg/m^2, inclusive, at screening.
- •Female participants of non-childbearing potential must have unequivocal documentation that they are not of childbearing potential Postmenopausal female participants must have a serum follicle-stimulating hormone (FSH) concentration >33.4 milli-international units per milliliter (mIU/mL) at screening to confirm menopause.
- •Male participants, if not surgically sterilized and who have a female partner of childbearing potential, must agree to use a condom during any sexual intercourse until the completion of the follow-up visit.
- •Male participants must agree not to donate sperm from admission on Day -1 until the completion of the follow-up visit.
- •All prescribed medication must have been stopped at least 30 days and >5 half-lives prior to admission to the clinical site on Day -
- •All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications must have been stopped at least 14 days prior to admission to the clinical site on Day -
- •An exception is made for paracetamol that is allowed up to admission to the clinical site on Day -
- •Ability and willingness to abstain from alcohol from 48 hours prior to screening and admission to the clinical site on Day -1 until the last PK sample.
- •Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, black tea, green tea, white tea, cola, chocolate, energy drinks), and grapefruit (juice) from 48 hours prior to admission to the clinical site.
- •Good physical and mental health based on medical history, physical examination, clinical laboratory, electrocardiogram (ECG), and vital signs, as judged by the Investigator.
排除标准
- •Employee of ICON, the Sponsor, GSK or associated vendors.
- •History of relevant drug and/or food allergies.
- •History of drug hypersensitivity, delayed-type hypersensitivity, or severe hypersensitivity reactions, as well as history of sensitivity to the study drug.
- •Using tobacco/nicotine products within 60 days prior to the first study drug administration.
- •History of alcohol abuse or drug addiction within 5 years prior to screening.
- •Positive drug and/or alcohol screen at screening or admission to the clinical site.
- •Average intake of more than 24 units of alcohol per week.
- •Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies at screening.
- •Participation in a drug study with a small molecule drug within 30 days or 5 half-lives if known (whichever is longer) prior to the first study drug administration in the current study. Participation in a clinical study with a biological within 90 days or 5 half-lives if known (whichever is longer) prior to the first study drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to the first study drug administration in the current study.
- •Donation or loss of more than 450 mL of blood within 60 days prior to the first study drug administration. Donation or loss of more than 1.5 L of blood (for male participants)/more than 1.0 L of blood (for female participants) in the 10 months prior to the first study drug administration in the current study.
- •Significant and/or acute illness within 14 days prior to the first study drug administration that may impact safety assessments, in the opinion of the Investigator.
- •Any significant current/ongoing known or suspected pre-existing psychiatric condition, including depression, anxiety, and/or insomnia/sleep disturbances and/or suicidal ideation, in the opinion of the Investigator.
- •Unsuitable veins for infusion or blood sampling.
- •Participation in a study with a 14C dose of ≥0.1 megabecquerel (MBq) in the period of 1 year prior to screening.
- •Irregular defecation pattern.
- •Pre-existing clinically relevant, in the opinion of the Investigator in discussion with the Sponsor medical monitor, gastro-intestinal pathology or diagnosis, eg, irritable bowel syndrome, inflammatory bowel disease, and/or significant baseline signs and symptoms.
- •History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drugs, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits, in the opinion of the Investigator. The Investigator may contact the Sponsor medical monitor to discuss the inclusion of participants who have a history of specific conditions that are not expected to interfere with their participation in the study.
研究组 & 干预措施
VH4524184 Group
Experimental
Participants will receive a dose of VH4524184 under fasting conditions, followed by a microdose of radiolabelled [14C]VH4524184 administered 2.5 hours after first dose administration at time zero on Day 1 (Period1). After a 14 days wash-out period participants will receive a radiolabelled dose of [14C]VH4524184 on Day 15 under fasting conditions.
干预措施: [14C]VH4524184 microdose (Drug)
VH4524184 Group
Experimental
Participants will receive a dose of VH4524184 under fasting conditions, followed by a microdose of radiolabelled [14C]VH4524184 administered 2.5 hours after first dose administration at time zero on Day 1 (Period1). After a 14 days wash-out period participants will receive a radiolabelled dose of [14C]VH4524184 on Day 15 under fasting conditions.
干预措施: [14C]VH4524184 (Drug)
VH4524184 Group
Experimental
Participants will receive a dose of VH4524184 under fasting conditions, followed by a microdose of radiolabelled [14C]VH4524184 administered 2.5 hours after first dose administration at time zero on Day 1 (Period1). After a 14 days wash-out period participants will receive a radiolabelled dose of [14C]VH4524184 on Day 15 under fasting conditions.
干预措施: VH4524184 (Drug)
研究者
研究点 (1)
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