NL-OMON51216已完成不适用
A two parts, open-label, single-dose mass balance and absolute bioavailability study with an oral regular dose of PHA-022121 and an oral (part 1) and intravenous (part 2) microtracer dose of 14C-PHA-022121 in healthy male subjects - ADME with 14C PHA-022121 in healthy male subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
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 64（—）
入选标准
- •1. Subject must be a healthy male, between 18 to 65 years of age, extremes
- •included, at screening.
- •2. Subject must have a body mass index (BMI; weight in kg divided by the square
- •of height in meters) 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 up
- •to and including 90 days after receiving the study drug), a male subject may be
- •enrolled if he is willing and able to adhere to the contraceptive requirement
- •as specified in 4.5 item 12 in the protocol.
- •5. Subject must be willing and able to adhere to the prohibitions and
- •restrictions.
- •Further criteria apply.
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 < 61 mL/min/1.73m2 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 National Cancer Institute (NCI) 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 (>1.1 x upper limit of normal
- •range [ULN])
- •- Hemoglobin below LLN (reference of site);
- •- Platelet count below LLN;
- •- Absolute neutrophil count lowering grade 1 or greater (<=1,5 109/L );
- •- 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 total
- •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, at screening, 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).
- •Further criteria apply.
研究者
相似试验
进行中（未招募）
1 期
A study in healthy male volunteers to investigate how the test medicine COMP360 [14C]-psilocybin is taken up, broken down and removed from the bodyTreatment-resistant depression (TRD). Study to be conducted in healthy volunteersMental and Behavioural DisordersISRCTN37167117Compass Pathfinder Limited6
Unknown
不适用
A study of Etoposide Capsules 100 mg with Vepesid Soft Capsules 100 mg in patients with lung cancer.CTRI/2019/11/022127INTAS PHARMACEUTICALS LIMITED9
已完成
不适用
Bioavailability study of Fentanyl CitrateCTRI/2014/10/005091Troikaa Pharmaceuticals Limited18
已完成
Unknown
Open label, balanced, randomized, single dose, two treatment, two sequence, two period, crossover oral bioequivalence study in healthy adult human male subjects under fasting conditions.CTRI/2023/08/056242Adeptio Pharmaceutical Limited
已完成
1 期
Comparative assessment in healthy male volunteers under fasting conditions of the absorption and pharmacokinetics of 1 generic formulation of (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid capsule against the innovator (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid capsuleIs used in the treatment of severe psoriasis in adult patients who have not responded to standard treatments.Skin - Dermatological conditionsACTRN12621000332820Zenith Technology Corporation Limited27