ACTRN12620001244998招募中1 期
A phase 1, single-center, randomized, open-label, 3-way crossover study to evaluate the systemic exposure after administration of a tablet formulation of PBT434 in the fed and fasted states compared to a powder in capsule formulation in healthy volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 42
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 75 Years（—）
- 性别
- All
入选标准
- •1. Male or female between 18 and 65 years old (inclusive) (Parts I and II) or 18-75 years old (Part III) at the time of consent.
- •Note: Part III will include at least 4 subjects =50 years old
- •2. In good general health, free from clinically significant medical or psychiatric illness
- •based on medical/surgical history, physical examination, 12-lead ECG, and clinical laboratory tests
- •3. Vital signs within ranges and stable (measured in supine position after 5 minutes rest)
- •4. Body Mass Index greater than or equal to 18kg/m2 and less than or equal to 30 kg/m2
- •5. Adequate venous access in the left or right arm to allow collection of the required number of blood samples
- •6. Provides written informed consent
- •7. Willing to comply with all study procedures and requirements, including consumption of a standardized high-fat, high calorie meal
- •8. Women of childbearing potential are using two acceptable methods of contraception through 90 days after the final dose
- •9. Male subjects must be using an acceptable birth control method through 90 days after the final dose
- •10. Female subjects must agree to not donate ova for 90 days after the final dose. Male subjects must agree to not donate sperm for 90 days after the final dose
- •11. No significant changes to diet within the 30 days prior to dosing through study completion
- •12. Willing and able to abstain from caffeine from 48 hours prior to check-in through 48 hours after dosing in each study period
排除标准
- •1. Women who are pregnant or breastfeeding
- •2. History or presence of malignancy, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix, which are allowed
- •3. Evidence of any clinically relevant medical illness, including cardiovascular, hematological, gastrointestinal, hepatic, renal, rheumatologic, endocrine, pulmonary, neurologic, psychiatric or skin disorders
- •4. Clinically significant surgical procedure within 3 months prior to screening or anticipated surgery during the study
- •5. History of epilepsy (other than febrile seizures during childhood)
- •6. History of head trauma with loss of consciousness, amnesia or skull fracture
- •7. Currently suffers from clinically significant systemic allergic disease or has a history of significant drug allergies including a history of anaphylactic reaction; allergic reaction due to any drug which led to significant morbidity
- •8. Unable to swallow study medication
- •9. History or presence of cardiac arrhythmia or congenital long QT syndrome
- •10. QTcF >450 msec for men or >470 msec for women on screening or baseline ECG
- •11. Use of any tobacco or nicotine containing products (including social use) in the 3 months prior to dosing or a positive urine cotinine test prior to dosing
- •12. Regular alcohol consumption >2 units/day (1 unit = 250 mL of beer, 100 mL of wine, or 30 mL of distilled spirits or liquor) or alcohol consumption within 24 hours prior to dosing until study completion
- •13. Positive urine drug or alcohol breathalyzer test prior to study entry (during screening or Day -1) or during the study, or history of alcohol or drug abuse in the 12 months prior to dosing
- •14. Evidence of renal insufficiency, as indicated by an estimated creatinine clearance <90 mL/min using the Cockcroft-Gault equation
- •15. Any of the following abnormalities in liver enzymes at Screening or Baseline:
- •a. Aspartate transaminase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of normal (ULN)
- •b. Alkaline phosphatase (ALP) or total bilirubin (TBil) >2 times the ULN
- •16. Hemoglobin value less than the lower limit of normal
- •17. Positive results of serology screening for hepatitis B (hepatitis B surface antigen [HBsAg]), hepatitis C (anti-hepatitis C virus [HCV] antibodies) or HIV (HIV antibodies type 1 and 2)
- •18. Any acute illness, clinically significant infection or clinically significant abnormal laboratory result within 28 days prior to dosing
- •19. Use of any prescription medication within 28 days prior to dosing
- •20. Use of any non-prescription medication (including non-steroidal anti-inflammatory drugs), herbal remedy (including St. John’s Wort) or vitamin supplement, within 14 days prior to dosing and throughout the study
- •Note: Approved doses of paracetamol (acetaminophen, up to a maximum of 2,000 mg/day) may be permitted during Screening and while on study at the investigator’s discretion.
- •21. Use of an investigational drug or device within 28 days or 10 half-lives of the drug, whichever is longer, prior to start of dosing (or within 6 months prior to Day -1 if investigational drug was a biologic)
- •22. Clinically significant blood loss or blood or plasma donation >550 mL within 90 days prior to start of dosing
- •23. As a result of history and physical examination, the Investigator considers the subject unfit for the study
- •24. Any condition (e.g., chronic diarrhea,
研究者
相似试验
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 subjectsACTRN12619000962134XW Laboratories (Australia) Pty Ltd8
进行中（未招募）
1 期
A study in healthy volunteers to investigate how different recipes and the particle size of an ingredient in the test medicine affects how the test medicine behavesMultiple sclerosisMultiple sclerosis (MS) (study conducted in healthy volunteers)Nervous System DiseasesISRCTN17780768Genentech, Inc. c/o F. Hoffmann-La Roche Ltd46
已完成
1 期
A Randomised, Open-label, Cross-over Study to Evaluate the Pharmacokinetics of a Single Dose of two Formulations of Orally Administered Tetrahydrocannabinol/Cannabidiol Combination in Fed Healthy Volunteers.PainAnaesthesiology - Pain managementACTRN12620000462987AusCann Group Holdings Ltd28
已完成
不适用
A Phase I, single-center, open-label, randomized four-period, randomized five-period or randomized two period crossover study to investigate the pharmacokinetics of five different DMF-containing formulations of FP187 and the comparator products Tecfidera® and Fumaderm® in healthy volunteers after oral administration in fasted or fed statePsoriasis, multiple sclerosispsoriasis10040790multiple sclerosisNL-OMON42556Forward Pharma GmbH84
进行中（未招募）
不适用
A study to compare two different forms of the same medicine (deferasirox tablet that is dissolved in liquid form vs. deferasirox film-coated tablet form) to see how much of each type of medicine ends up in the blood.Healthy subjectsEUCTR2016-000248-32-Outside-EU/EEAovartis Pharmaceuticals Corporation26