ACTRN12619000962134已完成1 期
A phase 1, randomized, open-label, single-center, pilot study to evaluate the food effect and pharmacokinetics of single oral doses of XW10172 and sodium oxybate in healthy adult subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •*Healthy male and female subjects age 18 to 45 years of age (inclusive). Healthy is defined as no clinically relevant abnormalities as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at Screening.
- •*Body mass index of 18 to 30 kg/m^2, inclusive, and a total body weight >50 kg (110 lbs).
- •*Female subjects of nonchildbearing potential, defined as surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or clinically documented to be postmenopausal (no regular menstrual bleeding for at least 1 year prior to study start and follicle-stimulating hormone >40 IU/L).
- •*Female subjects of childbearing potential must have a confirmed negative pregnancy test at the start of the study (Screening and Check-in) and also agree to abstain from sexual intercourse or use a highly effective method of birth control for the duration of the study, as determined by the investigator. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., <1% per year) when used consistently and correctly, such as condom + diaphragm, or intrauterine device (IUD) with documented failure rate of <1% per year, implanted hormonal contraceptives, or oral/injectable contraceptives used in combination with an additional barrier method.
- •Male subjects must agree to abstain from sexual intercourse or use a highly effective method of birth control with partners of childbearing potential for the duration of the study and for 1 month after last dose of study drug. A highly effective method of birth control in male subjects includes vasectomy or the use of a condom in combination with barrier methods, hormonal birth control or IUD by the female partner.
- •*Subjects with creatinine clearance greater than or equal to 60 mL/min and alanine aminotransferase, aspartate aminotransferase levels of less than or equal to 1.0 multiplied by upper limit of normal.
- •*Signed and dated written informed consent prior to admission to the study in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) and local regulations.
- •*Subjects who are willing and able to comply with the scheduled visits, laboratory tests, and other study procedures as stated in this protocol.
排除标准
- •* Evidence or history of clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, psychiatric, neurological, immunological or hormonal disorders, or allergic disease (including drug allergies, including immediate type hypersensitivity).
- •* History of major depression, obstructive sleep apnea, epilepsy, and seizures.
- •* Risk of suicidality at Screening as assessed using Columbia Suicide Assessment Test.
- •* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations.
- •* Donation or loss of 500 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
- •* Use of tobacco- or nicotine-containing products within 3 months prior to check-in and positive urine cotinine test at Screening or check-in.
- •* History of drug or alcohol abuse (>14 units per week for males or >7 units per week for females [1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits]) within the 5 years prior to dosing or evidence of such abuse as indicated by a positive urine drug screen and/or positive alcohol screen done at Screening or Check-in.
- •* Subjects with any condition which may affect drug absorption, distribution, metabolism, or excretion.
- •* Subject has clinically significant abnormalities on 12-lead ECG based on investigator’s judgment, or any of the following abnormalities at the screening visit or Day 1 predose: PR >200 msec, QRS complex >120 msec, and/or QTCF >450 msec.
- •* Subjects with pulse oximetry oxygen saturation levels <95% at Screening.
- •* Use of prescription or non-prescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to first dose of study drug. Subjects who are concurrently using any drug known to affect sleep-wake function.
- •* Subject is unwilling to abstain from any strenuous physical exercise (such as weight training, aerobics) 48 hours before the screening examination and 48 hours prior to study admission until the end of the study. Subject may exercise after the screening examination until 48 hours prior to study admission.
- •* Pregnant or breast-feeding women.
- •* Subjects with known hypersensitivity to any components of the study drug.
- •* Subjects are unwilling to comply with the protocol requirements, instructions, and study-related restrictions.
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