ACTRN12620001324909已完成1 期
A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose (SAD/MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Food Effect of GBT021601, a Hemoglobin S Polymerization Inhibitor, in Healthy Participants - Part A
inear Clinical Research Ltd0 个研究点目标入组 64 人开始时间: 2020年12月7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
- 64
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
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Healthy males or females between 18 and 55 years inclusive at screening.
- •2. No clinically significant findings as assessed by review of medical and surgical history,
- •vital signs assessments, 12-lead ECG, physical examination, and clinical laboratory
- •evaluations conducted at screening and on day of admission. In the event of clinically
- •significant abnormalities, a single repeat measurement/test may be performed at the
- •discretion of the investigator to confirm eligibility based upon initial vital signs, ECG, or
- •clinical laboratory tests.
- •3. Body mass index (BMI) between 18.0 and 30.0 kg/m^2 inclusive, and body weight more than or equal to50 kg at screening and Day -1. BMI = weight (kg)/(height[m])^2
- •4. Females must be of non-childbearing potential (eg, postmenopausal [defined as
- •amenorrhoeic for at least one year with a follicle stimulating hormone level >40 IU/L] or
- •surgically sterile by hysterectomy, bilateral tubal ligation, bilateral salpingectomy, or
- •bilateral oophorectomy [documentation required]).
- •5. Males who are not surgically sterile with partners of childbearing potential must agree to
- •use a highly effective method of birth control during the study and for 120 days following
- •study drug dose. A highly effective method of contraception is defined as one that results
- •in a low documented failure rate when used consistently and correctly such as: condom
- •plus use of an intrauterine device; intrauterine system or hormonal method of
- •contraception (oral, injected, implanted, or transdermal) for your female partner; or
- •sexual abstinence.
- •6. Males must agree to not donate sperm during the study and for 120 days following study
- •drug dosing.
- •7. Participants must be able to communicate effectively in English with the study personnel.
- •8. Participants must be nonsmokers, defined as having abstained from tobacco- or nicotine- containing products (eg, cigarettes, cigars, chewing tobacco, snuff, nicotine patches, and electronic cigarettes) in the 6 months prior to screening.
- •9. Participants must be informed of the nature and risks of the study and give written
- •consent prior to screening.
排除标准
- •1. Positive pregnancy test or currently breastfeeding.
- •2. History or presence of clinically significant allergic diseases (except for untreated,
- •asymptomatic, seasonal allergies) at time of dosing, in the opinion of the investigator.
- •3. History or presence of conditions which, in the opinion of the investigator, are known to
- •interfere with the absorption, distribution, metabolism, or excretion of drugs, such as
- •previous surgery on the gastrointestinal tract (including removal of parts of the stomach,
- •bowel, liver, gall bladder, or pancreas). Participants who have had an appendectomy are
- •eligible for enrollment.
- •4. History or presence of conditions that may place the participant at increased safety risk as determined by the investigator.
- •5. History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study.
- •6. Any signs and/or symptoms of acute illness, including COVID-19, at screening, Day -1, or Day 1.
- •7. Abnormal ECGs collected at screening or Day -1, including QT interval corrected for
- •heart rate (HR) using Fridericia’s formula (QTcF) >450 msec for males and >470 msec
- •for females, or any cardiac rhythm other than sinus rhythm that is interpreted by the
- •investigator to be clinically significant. An additional triplicate ECG may be performed
- •to confirm ECG abnormalities (ie, to confirm that a participant is eligible).
- •8. Known personal or family history of congenital long QT syndrome or known family
- •history of sudden death.
- •9. Resting bradycardia (HR <45 beats per minute [bpm]) or resting tachycardia
- •(HR >100 bpm) at screening or Day -1 based on vital signs measurements. A single
- •repeat measurement may be performed to confirm vital sign abnormalities (ie, to confirm
- •that a participant is eligible). Each of the readings must be not clinically significant to
- •qualify for enrollment into the study.
- •10. Hypertension, defined as resting systolic blood pressure (BP) >140 mmHg or resting
- •diastolic BP >90 mmHg at screening or Day -1. A single repeat measurement may be
- •performed to confirm vital sign abnormalities (ie, to confirm that a participant is eligible).
- •Each of the readings must be not clinically significant per the investigator’s discretion to
- •qualify for enrollment into the study.
- •11. History of alcohol abuse or use of drugs of abuse in the 12 months prior to the date of
- •consent. Excess alcohol is defined as more than 14 drinks/week for women and 21 drinks/week for men. A drink is defined as 360 mL of beer 150 mL of wine, or 45 mL of spirits.
- •12. Use of prescription medications within 14 days or 5 half-lives, whichever is longer, or
- •any over-the-counter (OTC) drugs, including herbal preparations or dietary supplements
- •within 7 days or 5 half-lives, whichever is longer, prior to Day -1 or requiring continued use during study participation. Occasional use of acetaminophen/paracetamol (e.g. up to 2g/day) is permitted up to 24 hours before the first dose.
- •13. Consumption of more than 400 mg of caffeine (approximately 4 cups of coffee) per day
- •within 30 days of screening or unwillingness to abstain from consumption of caffeine- or
- •xanthine-containing products (eg, tea, coffee, chocolate, cola, etc.) from 48 hours prior to
- •dosing (Day 1) through Day 7 (Part A) and from 48 hours prior to dosing and through
- •Day 21 (Part B).
- •14. Unwillingness to abstain from alcohol from 48 hours prior to dosing (Day 1) through
- •15. Consumption of grapefruit and/or grapefruit juic
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