NL-OMON49497已完成不适用
A single ascending dose trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of orally administered AS-0871 in healthy subjects - 190388-CS0338
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Must have signed an ICF prior to screening, indicating that he/she
- •understands the purpose of, and procedures required for, the trial, and
- •indicating that he/she is willing to participate in the trial.
- •2. Healthy males or females of non-childbearing potential, between 18 and 64
- •years of age, inclusive, at screening.
- •3. Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening.
- •4. Good physical and mental health as established by medical history, physical
- •examination, ECG, and vital signs (including temporal body temperature)
- •recording, and results of biochemistry, haematology, and urinalysis tests
- •during screening as judged by the investigator.
- •5. Non-smoker/non-user of nicotine-containing products for at least 3 months
- •prior to screening, to be confirmed by a urine cotinine dipstick test at
- •screening and on Day -1 of the first treatment period of each cohort.
- •6. Availability and willingness to complete the trial and follow the
- •instructions of the investigator or trial-site personnel.
- •7. Willing and able to adhere to the prohibitions and restrictions specified in
- •the protocol.
- •8. Easy venous accessibility.
- •9. During the trial (from the day of first trial medication onwards) and for a
- •minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after the
- •last trial medication intake, a male subject must agree:
- •to wear a condom when engaging in any activity that allows for passage of
- •ejaculate to another person (male subject should also be advised of the benefit
- •for a female partner to use a highly effective method of contraception as
- •condom may break or leak);
- •not to donate sperm for the purpose of reproduction.
- •Contraceptive use should be consistent with local regulations regarding the use
- •of contraceptive methods for subjects participating in clinical trials.
- •10. At screening, a female subject must be not of childbearing potential
- •defined as:
- •postmenopausal A postmenopausal state is defined as no menses for > 12 months
- •without an alternative medical explanation. A high follicle stimulating hormone
- •(FSH) level (> 40 IU/L or mIU/mL) in the postmenopausal range may be used to
- •confirm a postmenopausal state in women not using hormonal contraception or
- •hormone replacement therapy. In the absence of > 12 months of amenorrhea, 2 FSH
- •measurements have to be available, measured at least 3 months apart,
- •permanently sterile Permanent sterilization methods include hysterectomy,
- •bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and
- •bilateral oophorectomy.
- •11. Female subject, except if postmenopausal, must have a negative highly
- •sensitive serum (*-human chorionic gonadotropin [*-hCG]) pregnancy test at
- •screening and female subject must have a negative urine pregnancy test on Day
- •-1 of the first treatment period of each cohort.
- •12. Female subject must agree not to donate eggs (ova, oocytes) for the
- •purposes of assisted reproduction during the trial and for at least 90 days
- •after the last trial medication intake in the last treatment period.
- •13. Able to communicate well with the investigator, in the local language, and
- •to understand and comply with the requirements of the trial.
排除标准
- •1. History of or current clinically significant medical illness including (but
- •not limited to) gastrointestinal, cardiovascular, neurologic, psychiatric,
- •metabolic, endocrinologic, genitourinary, renal, hepatic, respiratory,
- •inflammatory, neoplastic, haematologic, or infectious disease, or any other
- •illness that the investigator considers should exclude the subject or that
- •could interfere with the interpretation of the trial results.
- •2. Clinically relevant abnormal values for haematology, biochemistry, or
- •urinalysis at screening or on Day -1 of the first treatment period, as judged
- •by the investigator.
- •3. Values of hepatic aminotransferase (ALT and/or AST) > 1.5 × the upper limit
- •of normal range (ULN) at screening or on Day -1 of the first treatment period.
- •4. Values of GGT and/or ALP > 1.25 x ULN at screening or on Day -1 of the first
- •treatment period.
- •5. Values of total cholesterol > ULN and LDL cholesterol > 1.25 x ULN at
- •screening or on Day -1 of the first treatment period.
- •6. Values of total bilirubin > ULN at screening or on Day -1 of the first
- •treatment period.
- •7. Values of urea >1.5 × ULN at screening or on Day -1 of the first treatment
- •8. A QTcF > 450 ms for male subjects and > 470 ms for female subjects.
- •9. Clinically significant abnormal complete physical examination at screening
- •or on Day -1 of the first treatment period, or clinically significant abnormal
- •symptom-driven physical examination at predose on Day 1 of the first treatment
- •period (if applicable), or clinically significant abnormal values for vital
- •signs (including temporal body temperature) or 12-lead ECG at screening or at
- •predose on Day 1 of the first treatment period, as judged by the investigator.
- •10. Clinically significant presence or history of allergy or intolerance
- •(including lactose) as judged by the investigator.
- •11. Previously demonstrated clinically significant allergy or hypersensitivity
- •to any of the components of the trial medication (see IB8).
- •12. Positive serology for hepatitis A virus (HAV) immunoglobulin M (IgM),
- •hepatitis B virus surface antigen (HBsAg), anti-hepatitis C virus antibodies
- •(anti-HCV-AB), or anti human immunodeficiency virus antibodies 1 + 2
- •(anti-HIV-AB 1 + 2) at screening.
- •13. History of alcohol or drug abuse within the last 2 years before screening
- •or positive test result(s) for alcohol and/or drugs of abuse at screening or on
- •Day *1 of the first treatment period of each cohort.
- •Note: A positive alcohol and/or drug test may be repeated once (as soon as
- •possible and within the screening period) to exclude a technical error.
- •Subjects with a negative alcohol and/or drug test at retest may be included.
- •14. Regular alcohol consumption > 14 units per week (1 unit = a 200-mL glass of
- •average-strength beer, 25 mL of 40% spirit. A 125-mL glass of wine is 1.5 unit).
- •15. A history of cancer excluding carcinoma in situ or intra-mucosal cancer.
- •16. Surgery of gastro-intestinal tract that might interfere with absorption
- •(subjects who have had cholecystectomy may be included). Subject has currently
- •significant and active diarrhoea, nausea, or constipation that in the
- •investigator*s opinion could influence drug absorption or bioavailability.
- •17. Intake of any disallowed therapies (see Section 5.10, Prior and Concomitant
- •Medication) before the first trial medica
研究者
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