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临床试验/ACTRN12623000736640
ACTRN12623000736640尚未招募1 期

An open-label, multiple dose study to compare the single-dose and steady-state pharmacokinetics of a 40 mg PHA-022121 extended-release (XR) tablet administered once daily between healthy Japanese, Chinese, and Caucasian volunteers.

Pharvaris Netherlands B.V.0 个研究点目标入组 36 人开始时间: 2023年7月7日最近更新:
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适应症

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
36
研究概览研究设计入排标准研究者记录与标识符相似试验

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
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 65 Years（—）
性别
All

入选标准

  • •1. Subject must sign an ICF indicating that the subject understands the purpose of the study
  • •including the procedures required, potential risks involved, and is willing to participate in the study before starting any screening activities.
  • •2. Subject must be healthy, between 18 to 65 years of age (inclusive)at the time of informed
  • •3. Subject must have a body mass index (BMI; weight in kg divided by the square of height in meters) between 17.0 and 32.0 kg/m2, extremes included, and a body weight between 45.0 kg and100.0 kg (inclusive), at screening
  • •4. A female subject may be enrolled if she is willing and able to adhere to the contraceptive
  • •requirement as follows:
  • •- documented to be surgically sterile or postmenopausal: Permanent sterilisation methods
  • •include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
  • •- practicing true abstinence for at least 21 days prior to dosing and until 90 days after study
  • •drug administration. The reliability of sexual abstinence needs to be evaluated if it is the
  • •preferred and usual lifestyle of the subject.
  • •- using two forms of medically acceptable and effective contraception:
  • •1) where one should be a highly effective method such as a hormonal method (e.g.,
  • •contraceptive implants, injectables, oral contraceptives), or a non-hormonal method
  • •(e.g., intrauterine device), from Screening or at least 2 weeks prior to study drug
  • •administration (whichever is earlier) until 90 days after the study follow-up visit,
  • •2) and the other should be a physical barrier method.
  • •- Two forms of above-mentioned contraception are not needed if the male partner is
  • •sterilized.
  • •- Contraception is not needed for same-sex contacts.
  • •5. All female subjects must have a negative serum ß-human chorionic gonadotropin (ß-hCG)
  • •pregnancy test at Screening and at Day -1 of each treatment period.
  • •6. Subject must be willing and able to adhere to the prohibitions and restrictions as follows:
  • •-Subject must remain at the clinical site throughout the study duration.
  • •-Within 7 days before first study drug administration and throughout the study, the use of prescription and nonprescription medication (including vitamins and herbal supplements) other than the study drug are prohibited.
  • •-The use of paracetamol is allowed up to 72 hours prior to the first study drug administration (Day 1). After that and at the discretion of the Investigator, a maximum of 1000 mg dose per day paracetamol, will be allowed for the treatment of headache or other pain.
  • •-The use of hormonal contraceptives or hormonal replacement therapy is allowed for female subjects of child-bearing potential or post-menopausal respectively.
  • •-Subject must not consume food or beverages containing alcohol or quinine (e.g., tonic water, bitter lemon, etc.) from 48 hours prior to admission to the clinical site and during clinical site confinement.
  • •-Subject must not consume grapefruit or grapefruit juice, pomelo juice, star fruit, or Seville orange products starting from 72 hours before the first PK sample is drawn and during clinical site confinement.
  • •-Subject must refrain from any methylxanthine containing products, (e.g., chocolate bars or chocolate beverages, coffee, teas, colas, etc.) from 48 hours before administration of study drug and during clinical site confinement.
  • •-Subjects are advised not to consume

排除标准

  • •1. Subject has a history of current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (estimated creatinine clearance < 90 mL/min/1.73m2 at screening, calculated by Crockfault-Gault formula), thyroid disease, neurologic or psychiatric
  • •disease, infection, or any other illness, that in the investigator’s and/or sponsor’s medical
  • •monitor opinion should exclude the subject or that could interfere with the interpretation of the study results.
  • •2. Subject has one of the following laboratory abnormalities at screening as defined by the
  • •Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, 27 November 2017
  • •and in accordance with the normal ranges of the clinical laboratory if no gradings are available.
  • •-Serum creatinine elevation grade 1 or greater than (>1.1 x upper limit of normal range [ULN])
  • •-Hemoglobin below lower limit of normal range (LLN), per Investigator discretion
  • •-Platelet count below LLN, per Investigator discretion
  • •-Absolute neutrophil count lowering grade 1 or greater than and equal to (1.5 109/L)
  • •-Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > (greater than) ULN
  • •-Total bilirubin > (greater than) ULN
  • •-Any other toxicity grade 2 or above, except for grade 2 elevations for triglycerides, low density lipoprotein (LDL) cholesterol and/or total cholesterol.
  • •3. Subject underwent surgery or has a medical condition that might significantly affect absorption of medicines (e.g., stomach bypass, cholecystectomy, etc.) as judged by the Investigator.
  • •4. Subject has clinically significant abnormal values for hematology, clinical chemistry or
  • •urinalysis at screening or at admission to the clinical site on Day -1 as judged by the
  • •investigator.
  • •5. Subject, at screening, has a positive test of human immunodeficiency virus (HIV) 1 and 2
  • •antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.
  • •6. Subject has a history of heart arrhythmias, tachycardia at rest, or history of risk factors for
  • •Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT syndrome, etc.).
  • •7. Subject has known allergies, hypersensitivity, or intolerance to PHA-022121’s excipients.
  • •8. Subject received a known potent inhibitor of cytochrome CYP3A activity (e.g., erythromycin, clarithromycin, ketoconazole or itraconazole) within 30 days before the first dose of the study drug is scheduled.
  • •9. Subject received a strong inducer of CYP3A activity (e.g., rifampin, St. John’s Wort) within
  • •30 days before the first dose of study drug is scheduled.
  • •10. Subject used any prescription or nonprescription medication (including vitamins and herbal supplements) within 7 days before first study drug administration is scheduled. The use of paracetamol (maximum 1000 mg per day) is allowed up to 72 hours prior to the first study drug administration (Day 1). The use of hormonal contraceptives is allowed for female
  • •subjects with child-bearing potential and the use of hormonal replacement therapy is allowed for post-menopausal female subjects.
  • •11. Subject has an average intake of more than 21 units of alcohol per week for males or 14 unites of alcohol for females. One (1) unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35m

研究者

发起方
Pharvaris Netherlands B.V.

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