NCT07800429尚未招募1 期
A Phase 1, Open-label Study to Evaluate the Effect of a Known P-gp Inhibitor, Itraconazole, on the Pharmacokinetics of Engasertib in Healthy Adult Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 27
- 主要终点
- Area Under the Concentration-time Curve (AUC) from Zero to the Last Quantifiable Concentration (AUC0-tlast) of Engasertib
研究概览
简要总结
The primary objective of this trial is to assess the effect of a known P-gp inhibitor, itraconazole, on the PK of engasertib in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Age of 18 to 55 years (both inclusive), at the time of signing the informed consent.
- •Body weight ≥ 50 and < 120 kg and a body mass index (BMI) within the range 18 to 30 kg/m^2 (both inclusive) at screening.
- •Male and female participants are eligible to participate if they are not fertile or if they agree to either be abstinent from intercourse where pregnancy can occur or use contraception/barrier as detailed in the protocol.
- •Overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, electrocardiogram (ECG).
- •Clinically acceptable clinical laboratory test results at screening.
- •Non-smoker, former smoker or stable non-smoker (= 0 cigarettes, pipes, cigars, or others) for at least 3 months prior to screening. Participants must also have abstained from use of other nicotine containing products (e.g., nicotine patch, chewing gum or e-cigarettes) for at least 3 months before screening.
- •Capable of giving signed informed consent.
- •Re-admission: overtly healthy as determined by medical evaluation including check of changes in medical history compared to screening, clinical laboratory test results, abbreviated physical examination, vital signs, and ECG.
排除标准
- •Any history or evidence of any clinically relevant cardiovascular, hepatic, renal, gastrointestinal, pancreatic, endocrinologic, hematologic, immunologic, metabolic, and/or other major disease or malignancy as determined by medical evaluation (including physical examination) 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.
- •Any clinically important illness, medical/surgical procedure, or condition, which, in the opinion of the investigator, is likely to interfere with the study conduct.
- •Known or suspected hypersensitivity to engasertib, or itraconazole, or any components of the formulation used.
- •History of significant or uncontrolled skin disorders, per the Investigator's judgement.
- •Any clinically significant history of allergic conditions (including allergies to more than 3 allergens, drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •History or presence of disorders of glucose metabolism.
- •Known or suspected thyroid disorders as evidenced by assessment of thyroid-stimulating hormone (TSH) levels outside the normal reference range at screening.
- •Known or suspected liver disorders (e.g., Morbus Gilbert / Meulengracht) and bile secretion/flow (cholestasis, also history of it).
- •Difficulty in swallowing.
- •History or evidence of malabsorption or any gastrointestinal surgery except appendectomy and herniotomy.
- •History of any chronic disease which might interfere with the absorption, distribution, metabolism or excretion of the study drug.
- •Lactose intolerance.
- •Contraindications for the use of itraconazole.
- •Tendency for vasovagal reactions (e.g., after venipuncture) or history of syncope.
- •Febrile illness within 1 week before first dosing.
- •Diagnosis or history of immunodeficiency or increased susceptibility to severe infection, or a clinically significant infection within 4 weeks prior to screening.
- •Use of any concomitant medication or any drugs / medicines (including dietary supplements, natural and herbal remedies, and hormone replacement therapy) within 2 weeks or 5 times the half-life of the respective drug, whichever is longer, prior to screening. Occasional use of paracetamol (2 grams/day; medicinal products in their original packaging, approved and marketed in Germany) is permitted. Oral, injectable, implantable, and topical contraceptives are permitted.
- •Administration of live, attenuated, replication-competent vaccine(s) and vector-based or mRNA COVID-19 vaccine(s) within 1 month prior to screening or plans to receive such vaccines during the study.
- •Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to screening.
- •Use of any investigational drug or participation in any clinical study within 30 days or 5 half-life times of study intervention administered in a previous trial, whichever is longer, prior to the expected date of first administration of study intervention or planning to take other investigational drugs during the study.
- •Positive for hepatitis B virus (HBV) panel test (Hepatitis B virus surface antigen [HBsAg], Hepatitis B Core Antibody [HBcAb], Hepatitis B surface antibody [HBsAb]), hepatitis C virus (HCV) (RNA), human immunodeficiency virus (HIV) 1+2 antibodies and HIV-1 p24 antigen combined at screening.
- •Positive screen for alcohol, drugs of abuse and cotinine test at screening.
- •Supine systolic blood pressure > 140 mmHg or < 90 mmHg; diastolic blood pressure > 90 mmHg or < 50 mmHg and pulse rate < 50 bpm or > 90 bpm (measurements taken after participant has been resting in supine position for 5 min), and tympanic body temperature of < 35.9 and > 37.6°C at screening.
- •12-lead ECG with clinically relevant abnormality.
- •Elevations in alanine transaminase (ALT) > 1.1 x ULN, aspartate aminotransferase (AST) > 1.2 x ULN, serum bilirubin > 1.2 x ULN, creatinine ≥ 1.1 x ULN at screening.
- •Estimated glomerular filtration rate (eGFR) according to the Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation (2009) < 90 mL/min at screening.
研究组 & 干预措施
Engasertib 40 mg + Itraconazole 200 mg
Experimental
All participants will take a single oral dose of engasertib 40 mg on Day 1. Participants will then take itraconazole 200 mg orally once daily (QD) from Day 12 to Day 24. On Day 15, a single oral dose of engasertib 40 mg will be administered 1 hour after the itraconazole dose.
干预措施: Engasertib (Drug)
Engasertib 40 mg + Itraconazole 200 mg
Experimental
All participants will take a single oral dose of engasertib 40 mg on Day 1. Participants will then take itraconazole 200 mg orally once daily (QD) from Day 12 to Day 24. On Day 15, a single oral dose of engasertib 40 mg will be administered 1 hour after the itraconazole dose.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve (AUC) from Zero to the Last Quantifiable Concentration (AUC0-tlast) of Engasertib
时间窗: Day 1 up to Day 26
AUC from Zero to Infinity (AUC0-inf) of Engasertib
时间窗: Day 1 up to Day 26
Maximum Plasma Concentration (Cmax) of Engasertib
时间窗: Day 1 up to Day 26
次要结局
未报告次要终点
研究者
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