NL-OMON49496已完成不适用
An open-label, single-sequence crossover drug-drug interaction study to evaluate the effect of multiple oral doses of itraconazole on the pharmacokinetics of PHA-022121 in healthy subjects - DDI Itraconazole and PHA-022121 in healthy subjects
Pharvaris BV0 个研究点目标入组 14 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
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. Subject must be a healthy male or female subject, between 18 to 60 years of
- •age, extremes included, at screening.
- •2. Subject must have a body mass index between 18.0 and 30.0 kg/m2, extremes
- •included, and a body weight not less than 50.0 kg, inclusive, at screening.
- •3. Subject must sign an ICF indicating that he understands the purpose of the
- •study including the procedures required, and is willing to participate in the
- •study, including that he agrees to provide DNA samples for research, before
- •starting of any screening activities.
- •4. During the study and for a minimum of 1 spermatogenesis cycle (defined as
- •approximately 90 days) after receiving the last dose of study drug, a male
- •subject: - who is sexually active with a woman of child-bearing potential and
- •has not had a vasectomy, must agree to use a barrier method of contraception
- •(eg, condom or partner with occlusive cap [diaphragm or cervical/vault caps]).
- •In addition, their female partner should also use a highly effective method of
- •birth control (eg, hormonal contraception) for at least the same duration. -
- •Who is sexually active with a woman who is pregnant must use a condom. - Must
- •agree not to donate sperm.
- •5. A female subject must be of non-childbearing potential at screening, defined
- •as: - Postmenopausal. A postmenopausal state is defined as no menses for 12
- •months without an alternative medical cause. A high follicle stimulating
- •hormone (FSH) level at screening (>33.4 IU/L ) in the postmenopausal range may
- •be used to confirm a postmenopausal state in woman not using hormonal
- •contraception or hormonal replacement therapy, however in the absence of 12
- •months of amenorrhea, a single FSH measurement is insufficient. - Permanently
- •sterile. Permanent sterilization methods include hysterectomy, bilateral
- •salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral
- •oophorectomy.
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 at screening,
- •calculated by MDRD 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 World Health Organization (WHO) Toxicity Grade Scale and in
- •accordance with the normal ranges of the clinical laboratory if no gradings are
- •available. - Serum creatinine elevation grade 1 or greater (>1.1 x upper limit
- •of normal range [ULN])- Hemoglobin lowering grade 1 or greater (<=6.5 mmol ;
- •<=109 g/L); - Platelet count below LLN; - Absolute neutrophil count lowering
- •grade 1 or greater (<=1,5 109/ ); - Aspartate aminotransferase (AST) or alanine
- •aminotransferase (ALT) >= ULN; - Total bilirubin >= ULN; - Any other toxicity
- •grade 2 or above, except for grade 2 elevations for triglycerides, low density
- •lipoprotein (LDL) cholesterol and/or cholesterol.
- •3. Clinically significant abnormal values for hematology, clinical chemistry or
- •urinalysis at screening or at admission to the clinical site on Day -1 as
- •deemed appropriate by the investigator.
- •4. Subject has a positive test of human immunodeficiency virus (HIV) 1 and 2
- •antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies.
- •5. Subject has a history of heart arrhythmias, tachycardia at rest, or history
- •of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family
- •history of long QT syndrome).
研究者
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