ISRCTN90725219已完成1 期
A Phase I, prospective, double-blind, randomised, placebo-controlled, dose escalating study to assess the safety and tolerability of single and multiple oral doses of PH46A and the effect of the fasted and fed state on pharmacokinetics of PH46A in healthy volunteers
Trino Therapeutics (Ireland)0 个研究点目标入组 96 人开始时间: 2014年3月11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
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy male and female volunteers aged 18-55, as determined by medical history, physical examination, laboratory test values, vital signs and 12-lead ECGs at screening.
- •2. Non-smokers from at least three months before receiving the first dose of study drug and for the duration of the study.
- •3. Body mass index (BMI) = 18 and = 29 kg/m2
- •4. Body weight = 55 kg and = 100 kg at screening
- •5. Able to voluntarily provide written informed consent to participate in the study
- •6. Must understand the purposes and risks of the study and agree to follow the restrictions and schedule of procedures as defined in the protocol, as confirmed during the informed consent process.
- •7. Female volunteers less than one year post-menopausal must have a negative serum pregnancy test and be non-lactating.
- •8. Female volunteers who have been post-menopausal for more than one year and have elevated serum follicle stimulating hormone (FSH) or are treated with hormone replacement therapy (HRT) or female volunteers who have been permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy).
- •9. Male volunteers and female volunteers of child-bearing potential who are sexually active must use two highly effective methods of contraception with their partners throughout the study and for 30 days after completion of the study (female volunteers) or 90 days after completion of the study (male volunteers). Acceptable methods include: condom or occlusive cap (diaphragm or cervical/ vault caps) with spermicidal foam/ gel/ film/ cream/ suppository; male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); established use of oral, injected or implanted hormonal methods of contraception and placement of an intrauterine device or intrauterine system. True abstinence is an acceptable method only where this is already established as the volunteer?s preferred
- •and usual lifestyle.
- •10. Male volunteers must not donate sperm during the study and for 90 days after completion of the study.
- •11. Must be willing to consent to have data entered into The Over Volunteering Prevention System (TOPS).
- •12. An up to date medical history from the volunteer?s primary care physician to confirm that there is nothing in their medical history that would preclude their enrolment into this clinical study.
排除标准
- •1. Volunteers with history or presence of significant cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or current infection.
- •2. Laboratory values at screening or baseline which are deemed to be clinically significant, unless agreed in advance by the Sponsor?s Medical Representative and Principal Investigator.
- •3. Female volunteers who are pregnant or lactating.
- •4. Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- •5. Current or history of drug or alcohol abuse or a positive drugs of abuse or alcohol test at screening or check-in.
- •6. Participation in a clinical drug study during the 90 days preceding the initial dose in this study.
- •7. Any clinically significant illness within 30 days prior to study drug administration.
- •8. Donation of blood or blood products within 90 days prior to study drug administration, or at any time during the study, except as required by this protocol.
- •9. Volunteers who have a history or presence of any significant drug allergy.
- •10. Use of any prescription or over-the-counter medication (including vitamins, herbal and mineral supplements) within 14 days prior to study drug administration until the end of the study, with the exception of occasional paracetamol approved by the Investigator and Investigator approved contraceptives and HRT.
- •11. Strenuous exercise, as judged by the Investigator, within 72 hours prior to screening, within 72 hours prior to study drug administration and for the duration of the study until after the post-study medical.
- •12. Weekly alcohol intake exceeding the equivalent of 14 units per week for females or 21 units per week for males.
- •13. Consumption of alcoholic beverages within 24 hours prior to study drug administration and during study confinement.
- •14. Consumption of caffeine or xanthine-containing products within 24 hours prior to confinement and during study confinement.
- •15. Consumption of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade or other products containing grapefruit or Seville oranges within 7 days prior to confinement and during study confinement.
- •16. Volunteers who, in the opinion of the Investigator, are unsuitable for participation in the study.
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