ACTRN12619001413112已完成1 期
A Two Part, Open-Label, Fixed Sequence Study to Evaluate the Effects of Multiple Doses of Itraconazole and Fluoxetine on the Pharmacokinetics of a Single Dose of AK0529 in Healthy Volunteers
Ark Biosciences Pty Ltd0 个研究点目标入组 28 人开始时间: 2019年10月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
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
- •1.Completion of the written informed consent process.
- •2.Male or female subjects aged 18 to 55 years of age, with a body mass index (BMI) within the range of 18 to 30 kg/m2 (inclusive).
- •3.Subjects not pregant, or will not be pregant, and agreed to use effective contraception method(s) during the study per protocol requirement.
- •4.Good health based on no clinically significant findings in the medical history, physical examination, or clinical laboratory test results.
- •5.Willing and able to comply with all study activities and procedures.
排除标准
- •1.Has a QTcF interval > 450 msec.
- •2.Has a history or presence of prolonged QTc or family history of long QT syndrome.
- •3.Has any finding that, in the opinion of the investigator, would compromise the subject’s ability to fulfill the protocol visit schedule or study requirements.
- •4.Has current evidence, or history of any clinically significant medical or psychiatric condition or observed abnormality that could potentially compromise subject safety or evaluation of PK parameters.
- •5.If female, is currently pregnant or breastfeeding.
- •6.Has a history of, or current infection with, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus, or has a history of liver disease, including unexplained fluctuations in liver function tests.
- •7.Has used CYP3A4 or CYP2D6 inhibitors or inducers or P-gp inhibitors within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, or anticipates a need to use any CYP3A4 or CYP2D6 inhibitors or inducers, or P-gp inhibitors during the study period.
- •8.Use of prescription or non-prescription drugs, herbal products, nutritional supplements or ‘alternative’ medication or remedies within 14 days or 5 half-lives (whichever is the longer) prior to the first dose of study drug.
- •9.Intake of grapefruit, grapefruit juice or grapefruit-related citrus fruits within 7 days prior to the first dose of the study medication.
- •10.Has a known intolerance or allergy to AK0529, itraconazole, fluoxetine or related compounds.
- •11.Previous intolerance to SSRI or SNRI drugs.
- •12.Has a history or current presence of psychiatric symptoms including anxiety, mood disturbance, suicidal ideation or self-harming behaviour.
- •13.Has a history of seizure, except for simple, febrile convulsion as a child.
- •14.History of regular alcohol consumption exceeding a weekly intake of more than 21 units for males and more than 14 units for females within 6 months of screening.
- •15.Is a smoker, or has ceased using tobacco-containing or nicotine-containing products within 3 months of screening, not including light or social smoking not exceeding the equivalent of 5 cigarettes per week, and/or has a positive cotinine test at screening or Day -1.
- •16.Excessive consumption of beverages containing xanthine bases.
- •17.Has used alcohol-, caffeine- or xanthine-containing products within 72 hours prior to admission on Day -1.
- •18.Has a positive urine toxicological screen for cotinine (or saliva test), benzodiazepines, opioids amphetamine/methamphetamine, cannabinoids or cocaine at screening or Day -1.
- •19.Has a positive alcohol breath test at screening or Day -1.
- •20.Has donated blood of more than 500 ml within 4 weeks prior to screening.
- •21.Participation in any investigational product study within 12 weeks or five half-lives (whichever is longer) prior to the first dose of the study medication.
研究者
相似试验
已完成
不适用
Two-groups, open label, fixed-sequence study to evaluate the effect of CYP3A4/P-gp inhibition (Itraconazole) or CYP1A2/3A4 inhibition (Fluvoxamine) on the single-dose PK of MEN1611 in healthy subjects.Cancer with PIK3CA mutationtumorsCancerNL-OMON51334Menarini Richerche S.p.A.44
已完成
不适用
An open-label, two-period, fixed sequence study to evaluate the effects of multiple oral doses of AFQ056 on the pharmacokinetics of a monophasic oral contraceptive in healthy female volunteersFragile X Syndrome (FXS)interaction study1008362410029305mental retardationNL-OMON36456ovartis30
已完成
不适用
Open-label, 2-period, fixed sequence study to assess the bioavailability of aluminium, formulated as aluminium chlorohydrate, after topical application of a representative antiperspirant formulation in healthy women using a [26Al] microtracer approachGeneral healthNL-OMON46500Cosmetics Europe The Personal Care Association A.I.S.B.L.12
已完成
1 期
An Open-label, Single-arm, Two-period, Fixed Sequential-dose Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of SP 102 (Dexamethasone Sodium Phosphate Injectable Gel) Administered by Epidural Injection Compared with Dexamethasone Sodium Phosphate Injection, Administered by Intravenous Injection in Subjects with Lumbosacral RadiculopathyPainAnaesthesiology - Pain managementACTRN12619000448145Semnur Pharmceuticals16
已完成
1 期
Effect of HM30181A on the Pharmacokinetics of DigoxiCancerACTRN12618000798268Athenex Inc14