EUCTR2020-000369-18-BE进行中（未招募）1 期
A Phase 1, open-label, randomized, crossover study in healthy adult subjects to assess the relative oral bioavailability and food effect of a single 250-mg dose of JNJ-53718678 administered as oral solid concept formulation compared to a suspension and the effect of storage conditions of the suspension on the pharmacokinetics of JNJ-53718678
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Participant must be a man or woman 18 to 55 years of age, inclusive.
- •2. A woman must be
- •a. Not of childbearing potential
- •b. Of childbearing potential and
- •Practicing a highly effective, preferably user-independent method of contraception (failure rate of <1% per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until 30 days after last dose.
- •Have a negative highly sensitive serum (beta-human chorionic gonadotropin) at Screening
- •3. A male participant
- •who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (eg, condom with or without spermicidal foam/gel/film/cream/suppository) from the day of first study drug intake until 90 days after the last administration of study drug in the study, in conjunction with this female partner using a highly effective contraceptive (such as implantable progestogen-only hormone contraception associated with inhibition of ovulation; intrauterine device [IUD]; intrauterine hormone-releasing system [IUS], combined [estrogen- and progestogen- containing] hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal; progestogen-only hormone contraception associated with inhibition of ovulation: oral of injectable).
- •must be heterosexually abstinent (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse from the day of first study drug intake until 90 days after the last administration of study drug in the study).
- •4. A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction from Day 1 (of the first treatment period, as applicable) in the study until at least 30 days after study drug administration (in the last treatment period, as applicable).
- •5. A male participant must agree not to donate sperm for the purpose of reproduction from Day 1 of the study and for a minimum of 90 days after receiving the last dose of the study intervention.
- •6. Participant must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study before starting any screening activities.
- •7. Participant must be willing and able to adhere to the prohibitions and restrictions.
- •8. Participant must have a body mass index (BMI; weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included.
- •9. Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic.
- •10. Participant must have a normal 12-lead ECG consistent with normal cardiac conduction and function at screening, including:
- •-normal sinus rhythm (heart rate between 45 and 90 beats per minute, extremes included);
- •-QTcF interval =450 ms for men and =470 ms for women;
- •-QRS interval of =110 ms;
- •-PR interval =200 ms
- •11. Participants must be healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination (including height and body weight measurement and skin examination), medical history, vital signs (body temperature [tympanic], systolic blood pressure [SBP], diastolic blood pressure [DBP], pulse rate,), and the results of blood biochemistry and hematology tests, and
排除标准
- •1. Participant with a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic insufficiency, renal dysfunction (estimated glomerular filtration rate [eGFR] as calculated per Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] Creatinine Equation <60mL/min/m²), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the Investigator considers should exclude the participant or that could interfere with the interpretation of the study results.
- •2. Participants with one or more of the following laboratory abnormalities at screening, as defined by the World Health Organization (WHO) Toxicity Grading Scale:
- •-serum creatinine grade 1 or greater (=1.1 x upper limit of laboratory normal range [ULN]);
- •-lipase = grade 2, total amylase = grade 2;
- •-hemoglobin grade 1 or greater (=10.5 g/dL [105 g/L]);
- •-platelet count grade 1 or greater (=99.000/mm3 [99x109/L]);
- •-absolute neutrophil count grade 1 or greater (=1500/mm³ [1.5x109/L]);
- •-total bilirubin grade 1 or greater (=1.1 x ULN), participants with Gilbert’s syndrome can be allowed;
- •-any other toxicity grade 2 or above, except for grade 2 elevations of triglycerides, LDL cholesterol and/or cholesterol;
- •-grade 1 or greater ALT and AST (>1.25 x ULN).
- •3. Participants with lack of good/reasonable venous access.
- •4. Participants with a past history of heart arrhythmias (extrasystole, tachycardia at rest) or, history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome or sudden cardiac death).
- •5. Participant has taken any disallowed therapies before the planned first dose of study drug.
- •6. Participants with a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, methadone and benzodiazepines) at screening and on Day -1 of each treatment period.
- •NOTE: A positive urine drug test and/or alcohol breath test may be repeated once to exclude a technical error. Participants with a negative urine drug and/or alcohol breath test at retest may be included.
- •7. Participant is breast-feeding at screening.
- •8. Participants with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria.
- •9. Participant has known allergies, hypersensitivity, or intolerance to JNJ-53718678 or its excipients.
- •10. Vulnerable participants (eg, incarcerated individuals).
研究者
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