ACTRN12621001349831已完成1 期
A Single Centre, Phase I, Randomised, Four-way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of a Single Dose of Two Different Formulations of IMG-7289 (Bomedemstat) Administered Orally in Healthy Adult Volunteers
Avance Clinical0 个研究点目标入组 17 人开始时间: 2021年10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
- 17
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Healthy volunteers will be included in this study if they satisfy all the following criteria:
- •1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- •2. Adult males and females, 18 to 65 years of age (inclusive) at screening.
- •3. BMI greater than or equal to 18.0 and less than or equal to 32.0 kg/m2, with a body weight greater than or equal to 55 and less than or equal to 100 kg at screening.
- •4. Be nonsmokers (including tobacco, e-cigarettes, marijuana or other nicotine containing product) for at least 3 months prior to first study drug administration and have a negative result of cotinine test at screening and on Day -1 for each confinement period.
- •5. No prior history of chronic alcohol abuse or excessive alcohol intake, at the discretion of the Principal Investigator (PI), within 12 weeks prior to screening, and negative alcohol test results.
- •6. No prior history of substance abuse or drug addiction within 12 months prior to first study drug administration and negative urine drug screen results at screening and on Day -1 for each confinement period. In the event the urinary drug test is positive, the test may be repeated once (at the discretion of the PI) to confirm eligibility.
- •7. No prior history of relevant drug hypersensitivity.
- •8. Medically healthy (in the opinion of the PI) as determined by pre-study medical history and without clinically significant abnormalities at screening and prior to first dose administration on Day 1, including.
- •a. Physical examination without any clinically relevant findings;
- •b. Systolic blood pressure in the range of 90 to 160 mmHg and diastolic blood pressure in the range of 50 to 95 mmHg after 5 minutes in supine position;
- •c. Heart rate in the range of 45 to 100 beats/minute after 5 minutes rest in supine position;
- •d. Body temperature (tympanic), between 35.5°C and 37.7°C;
- •e. A 12-lead electrocardiogram (ECG) within normal range or with abnormalities that are not hazardous to the participant according to the opinion of the PI;
- •f. No clinically relevant findings in clinical laboratory blood and urinalysis tests as judged by the PI.
- •The above assessments may be repeated once, if abnormal values were recorded in the first instance, at the discretion of the PI.
- •9. Female participants must:
- •a. Be of nonchildbearing potential
- •b. If of childbearing potential, must have a negative pregnancy test at screening (blood test) and before the first study drug administration (Day -1 urine test). They must agree not to attempt to become pregnant, must not donate ova, and must use a highly effective contraceptive method from signing the consent form until at least 30 days after the last dose of study drug.
- •c. Must not be breast-feeding.
- •10. Male participants, if not surgically sterilised, must be willing not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must be willing to use a condom in addition to having the female partner use a highly effective contraceptive method from signing the consent form until at least 90 days after the last dose of study drug.
- •11. Have suitable venous access for blood sampling.
- •12. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
排除标准
- •Healthy volunteers will be excluded from this study if there is evidence of any of the following at screening or after check in prior to dose administration on Day 1 (clinical and laboratory assessments may be repeated once, at the discretion of the PI, in the case of abnormal findings in the first instance):
- •1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant.
- •2. Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications.
- •3. Any history of malignant disease in the last 5 years (except basal cell skin cancer or squamous cell skin cancer with history of curative treatment and no recurrence for more than 1 year prior to screening).
- •4. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
- •5. Use of or plans to use systemic immunosuppressive (e.g., corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) during the study or within 4 months prior to the first study drug administration.
- •6. Liver function test results (i.e., aspartate aminotransferase [AST], alanine aminotransferase [ALT], and gammaglutamyl transferase [GGT]) and total bilirubin elevated greater than or equal to 1.5-fold above the normal limits.
- •7. Abnormal renal function tests, indicated by calculated creatinine clearance less than 80 mL/min, and serum creatinine greater than 1.5-fold of the normal range, respectively.
- •8. History of bleeding diathesis, thrombocytopenia or other clotting or coagulation disorder.
- •9. Platelets below the lower limit of normal (150 x 109/L).
- •10. Family history of long QT syndrome or of unexplained sudden death in a first-degree relative under 50 years of age.
- •11. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies.
- •12. Presence or having sequelae of gastrointestinal, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •13. Use of any prescription medication within 14 days or 7 half-lives of the medication (whichever is longer) prior to the first study drug administration (except hormonal contraceptives associated with inhibition of ovulation and other medication deemed non-clinically relevant by the PI in consultation with Imago BioSciences).
- •14. Use of over-the-counter medication excluding routine vitamins and herbal supplements (paracetamol less than 2 grams/day is acceptable) but including mega dose vitamin therapy and St John’s Wort within 7 days of first dosing and throughout the study, unless agreed as non-clinically relevant by the PI.
- •15. Consumption of caffeine or alcohol, or any products containing grapefruit, Seville orange, star fruit or pomegranate within 48 hours prior to the first IMG-7289 dose administration on Day 1 (consumption is also not permitted within 48 hours of Day 1 for each period).
- •16. Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions (e.g., food, drug, or atopic reactions, asthmatic episodes) which, in the opinion of the PI, would inter
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