ACTRN12624000878572尚未招募1 期
A Phase 1, Fixed Sequence, Open-Label Study to Evaluate the Effect of Multiple Doses of Rabeprazole on the Pharmacokinetics of a Single Dose of Radiprodil in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Volunteers will be included in the study only if they satisfy all the following criteria:
- •1.Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
- •2.Adult males and females, 18 to 55 years of age (inclusive) at screening.
- •3.Body mass index (BMI) greater than or equal to 18.0 and less than or equal to 32.0 kg/m2, with a body weight greater than 50 kg at screening.
- •4.Medically healthy (in the opinion of the PI or delegate), as determined by pre-study medical history, and without clinically significant abnormalities including the following:
- •a.Physical examination without any clinically relevant findings;
- •b.Systolic blood pressure in the range of 90 to 140 mmHg and diastolic blood pressure in the range of 40 to 90 mmHg after resting for 5 minutes in a supine or semi-supine position.
- •c.Pulse rate in the range of 40 to 100 bpm after 5 minutes resting in a supine or semi-supine position.
- •d.Body temperature (tympanic), between 35.5°C and 37.5°C.
- •e.Electrocardiogram without clinically significant abnormalities including QT interval corrected for Fredericia (QTcF) <450 msec for male participants and <470 msec for female participants.
- •f.No clinically significant findings in serum chemistry, hematology, coagulation, and urinalysis tests.
- •5.Female volunteers:
- •a.Must be of non-child-bearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone (FSH) level consistent with postmenopausal status, per local laboratory guidelines), or
- •b.If of child-bearing potential, must:
- •i.Have a negative pregnancy test at the screening visit and on admission to the study site on Day-1.
- •ii.Agree not to attempt to become pregnant or donate ova from signing the consent form until at least 90 days after the last dose of study drug.
- •iii.Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception) from one month prior to screening until at least 90 days after the last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle.
- •6.Male volunteers, if not surgically sterilised, must:
- •a.Agree not to donate sperm from signing the consent form until at least 90 days after the last dose of study drug.
- •b.If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception) from signing the consent form until at least 90 days after the last dose of study drug.
- •c.If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from signing the consent form until at least 90 days after the last dose of study drug.
- •7.Have suitable venous access for blood sampling.
- •8.Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
排除标准
- •Volunteers will be excluded from the study if they meet any of the following criteria:
- •1.Known hypersensitivity to the study drug or any of the study drug ingredients, or hypersensitivity to proton pump inhibitors.
- •2.History of suicide attempts or deliberate self-harm, or a score of 4 or 5 on ideation or any suicidal behaviour on the Columbia-Suicide Severity Rating Scale (C-SSRS).
- •3.History of anaphylaxis or other significant allergy (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic seasonal allergies at time of dosing on Day 1) which, in the opinion of the PI (or delegate), would interfere with the volunteer’s ability to participate in the study.
- •4.History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, determined by the PI (or delegate) to be clinically relevant.
- •5.History of surgery within 3 months prior to Day 1 as determined by the PI to be clinically relevant, or surgery planned during the study.
- •6.Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
- •7.History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known arrythmia.
- •8.Presence or having sequelae of gastrointestinal, liver (including Gilbert’s syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •9.Liver function test results elevated greater than 1.5-fold above the ULN for gamma glutamyl transferase (GGT), bilirubin (total, conjugated and unconjugated), ALP, AST or alanine aminotransferase (ALT). Volunteers with ALP and/or ALT/AST above the limits specified may be included, at the discretion of the PI (or delegate), if the levels are unaccompanied by clinical signs and are determined to be normal variants.
- •10.Estimated creatinine clearance (CrCl) < 60 mL/min using the Cockcroft-Gault formula or serum creatinine greater than 1.5-fold above the ULN.
- •11.A history of or positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
- •12.Positive drugs of abuse test, cotinine test or alcohol breath test results at the screening visit and/or on admission to the study site on Day 1.
- •13.Regular consumption of more than 10 standard alcoholic drinks/week and/or more than 4 standard alcoholic drinks on any one day, where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc/Vol], 100 mL wine [12% Alc/Vol], or 30 mL spirit [40% Alc/Vol]).
- •14.Routine consumption of an average of more than five (5) 240 mL servings of coffee or other caffeinated beverages per day.
- •15.Use of marijuana (including prescribed marijuana) within 30 days of Day -1.
- •16.Use of tobacco-containing products and nicotine or nicotine containing products in the 2 months prior to Day 1.
- •17.Females who are breastfeeding or planning to breastfeed.
- •18.Unable to swallow oral medication.
- •19.Use of any prescription or over-the-counter medication (including herbal products, diet aids, vitamins, and hormone supplements) within 14 days or 5 half-lives of the medication (whichever is longer) prior to the first dose of
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