ACTRN12615000936527已完成1 期
Relative Bioavailability and Effect of Food and Esomeprazole on the Pharmacokinetics of PRN1008 in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
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
- •* Healthy adult male or non-pregnant non-lactating females, 18 to 75 years of age (inclusive) at the time of screening
- •* Body mass index (BMI) greater than or equal to 18 and less than or equal to 35 (kg/m2) (inclusive) and a minimum body weight of 45 kg.
- •* Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
- •* A female subject of childbearing potential with a negative pregnancy test agrees to abstinence or use of condoms plus one other acceptable form of contraception; i.e. intrauterine device, hormonal contraception, or a female diaphragm, until 4 weeks after dosing with study drug OR has only same-sex partners, when this is her preferred and usual lifestyle
- •* Male subjects with female partners of childbearing potential must agree to use condoms for the duration of the study and until 4 weeks after dosing with the study drug
- •*Negative urine drug and alcohol testing at screening and check-in (Day -1). Screening urine drug and alcohol testing may be repeated once if deemed appropriate by the site Investigator.
- •* Willing to or has abstain(ed) from consuming grapefruit or Seville orange containing products from 14 days prior to first dose of study medication through follow-up.
排除标准
- •* Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV)
- •* History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration.
- •* History of any significant (as determined by the Investigator) drug-related allergic reactions such as, anaphylaxis, Stevens-Johnson syndrome, urticaria or multiple drug allergies.
- •*Blood donation or significant blood loss within 30 days prior to screening.
- •*Plasma donation within 14 days prior to the first study drug administration.
- •*Participation in another clinical trial of a drug or device whereby the last investigational drug/device administration is within 30 days prior to the first study drug administration or 5 half-lives, whichever is longer.
- •* Surgery within the past three months prior to the first study drug administration determined by the PI to be clinically relevant.
- •* Personal or family history of prolonged QT syndrome or family history of sudden death.
- •*QTcF greater than 450 msec (males) or greater than 470 msec (females) or less than 300 msec at screening or baseline visit, unless deemed clinically insignificant by the Investigator.
- •* Screening ECG with QRS and/or T-wave judged to be unfavorable for a consistently accurate QT measurement as judged by the Investigator.
- •* Evidence of atrial fibrillation, atrial flutter, complete bundle branch or heart block, Wolff-Parkinson-White Syndrome, or cardiac pacemaker at screening or baseline visit.
- •* Seated resting systolic blood pressure (SBP) greater than 150 or less than 90 mm Hg, or diastolic blood pressure greater than 95 or less than 50 mm Hg.
- •*Resting HR less than 45 bpm or greater than 90 bpm at screening or baseline (Day -1) visit (the heart rate recorded from vital sign assessment will be utilised for this exclusion criteria).
- •* Hypersensitivity or history of idiosyncratic reaction to any components or excipients of the investigational formulation
- •* Regular alcohol consumption greater than 14 units per week (1 unit equals half a pint beer, 25 mL of 40 percent spirit or a 125 mL glass of wine).
- •* Active infection
- •* Participant is febrile, temperature greater 37.5 degrees centigrade (assessed at Screening and at Baseline (Day -1))
- •* Any acute illness within 30 days prior to Day 1 unless deemed clinically insignificant by the Investigator and discussed with the Sponsor.
- •* History of seizure, whether epileptic, paroxysmal, or of unknown origin
- •* Failure to satisfy the Investigator of fitness to participate for any other reason
- •* History or presence of any other medical condition that makes the participant unsuitable for the study in the opinion of the Investigator.
研究者
相似试验
进行中（未招募）
不适用
To determine oral bioavailability of the oral liquid formulation and potential food effects.EUCTR2011-001893-24-DEBayer HealthCare AG30
进行中（未招募）
1 期
A clinical study in healthy adults to compare the bioavailability of Harvoni tablets to that of pediatric granules.EUCTR2017-003956-22-Outside-EU/EEAGilead Sciences, Inc.42
进行中（未招募）
不适用
Bioavailabity and food effects of the paediatric formulation of LDV/SOF in adult subjectsChronic Hepatitis C virus infectionMedDRA version: 18.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 18.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2015-003570-32-Outside-EU/EEAGilead Sciences, Inc.42
已完成
不适用
Do health benefits of vegetable derived compounds on healthy blood flow depend on the structure they were consumed in?ACTRN12611000656932ew Zealand Institute of Plant and Food Research25
已完成
不适用
Investigation on the bioavailability and metabolism of resveratrol an ingredient of berries in humanshealthy volunteersDRKS00008788Max Rubner-InstitutBundesforschungsinstitut für Ernährung und Lebensmittel107