ISRCTN18262237已完成1 期
A multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ENX-101 at plasma steady state in healthy volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 53
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
- 性别
- All
入选标准
- •1. Healthy male and female volunteers aged 18 to 55 years, inclusive, at Screening
- •2. Capable of giving written informed consent
- •3. Willing to give written consent to have data entered into Verified Clinical Trials
- •4. Female subjects
- •4.1. Of non-childbearing potential, defined as either permanently sterilized (at least 4 months after surgical sterilization including bilateral salpingectomy, tubal ligation, or oophorectomy with or without hysterectomy) or post-menopausal (defined as amenorrhea for 12 consecutive months and documented plasma follicle-stimulating hormone level >40 IU/mL; in the event a subject's menopausal status has been clearly established and yet serum follicle-stimulating hormone levels are not consistent with a post-menopausal status, determination of the subject's eligibility to be included in the study will be at the Investigator's discretion following consultation with the Sponsor), and with a negative pregnancy test at Screening and Day –2; OR
- •4.2. Of childbearing potential and willing to use two effective methods of contraception (i.e., established method of contraception + condom) or remain abstinent (where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from Day –2 through 3 months after the last dose of study drug, and with a negative pregnancy test at Screening and Day –2
- •5. Male subjects who, if fertile (defined as post-pubertal and not permanently sterile by orchidectomy or vasectomy) must be willing to use a condom or remain abstinent (where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from Day –2 through 3 months after the last dose of study drug
- •6. Body mass index of 18 to 35 kg/m2 at Screening
- •7. Willing and able to comply with all study requirements including the following:
- •7.1. Reside in the inpatient unit from Day –2 until discharge on Day 13
- •7.2. Refrain from strenuous exercise from Day –4 until Day 13
- •7.3. Abstain from grapefruit-, alcohol-, caffeine-, or xanthine-containing products from Day –4 through Day 13
- •Part 2 Subjects Only:
- •8. Subjects must have sleep pattern of going to bed between 10:00 pm and 12:00 am over the 4 weeks prior to Screening through to Day -29. Subjects must have been sleeping at least 6 to 8 hours per night over the 4 weeks prior to Screening through to Day -2
排除标准
- •1. Clinically significant abnormality within 2 years of Screening that in the Investigator’s opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, renal, neurologic, gastrointestinal, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy.
- •2. History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or CNS infections (e.g., meningitis).
- •3. History or evidence of significant ophthalmologic or neurologic condition that would adversely affect the eye movement assessments.
- •4. History or evidence of any medical condition potentially altering the absorption, metabolism, or elimination of drugs; this includes a surgical history of the gastrointestinal tract affecting gastric motility or altering the gastrointestinal tract.
- •5. Any of the following cardiovascular conditions at Screening or Day –1:
- •5.1. History or evidence of any of the following:
- •5.1.1. Myocardial infarction
- •5.1.2. Cardiac valvulopathy
- •5.1.3. Cardiac surgery revascularization (coronary artery bypass grafting or percutaneous transluminal coronary angioplasty)
- •5.1.4. Unstable angina
- •5.1.5. Cerebrovascular accident or stroke or transient ischemic attack
- •5.1.6. Pacemaker
- •5.1.7. Atrial fibrillation, flutter, or nonsustained or sustained ventricular tachycardia
- •5.1.8. Pulmonary arterial hypertension
- •5.1.9. Sick sinus syndrome, second- or third-degree atrioventricular block
- •5.1.10. Uncontrolled hypertension
- •5.1.11. Congestive heart failure
- •5.1.12. Family history of sudden death or personal history of long QT syndrome
- •5.1.13. Hypokalemia
- •5.1.14. Unexplained syncope or syncope within the last 3?years regardless of etiology
- •5.2. Electrographically and clinically significant abnormalities, as judged by the Investigator, that might interfere with ECG (electrocardiogram) analysis, including evidence of a previous myocardial infarction, significant left ventricular hypertrophy, flat T waves (particularly in the inferior leads), or more than minor nonspecific STT–wave changes.
- •5.2.1. Rhythm other than sinus rhythm
- •5.2.2. Mean HR <50 beats per minute (bpm) or >100 bpm
- •5.2.3. Mean systolic blood pressure >140 mmHg; mean diastolic blood pressure >90 mmHg
- •5.2.4. QTc interval using Fridericia’s formula (QTcF) >450 msec in males or >470 msec in females
- •5.2.5. QRS interval =120 msec
- •5.2.6. PR interval >200 msec
- •6. Reports having experienced suicidal ideation (Type 4 or 5 on the C-SSRS (Colombia-Suicide Severity Rating Scale)) within 30 days prior to Screening, any suicidal behavior within 2 years prior to Screening (any Yes” answers on the Suicidal Behavior section of C-SSRS) and/or the Investigator assesses the subject to be a safety risk to him/herself or others.
- •7. Diagnosis of any sleep disorder in the last 6 months or as judged significant by the Investigator or daytime symptoms attributable to unsatisfactory sleep or shift
研究者
相似试验
已完成
1 期
K757 and K833 multiple-dose study in healthy subjectsHealthy subjectsISRCTN13328584Kallyope (United States)36
进行中（未招募）
1 期
A multiple ascending dose study to evaluate the safety, tolerability and effect on tumor response of the mTOR inhibitor (RAD001) in combination with the IGF-1R antagonist (R1507) in patients with advanced solid tumorsPIb: solid malignancy that is metastatic or unresectable PII: C 1: Advanced metastatic renal cell carcinoma C 2: Advanced low- to intermediate grade metastatic or unresectable locoregional pancreatic neuroendocrine tumors + carcinoid tumorsMedDRA version: 9.1Level: LLTClassification code 10050076Term: Metastatic renal carcinomaMedDRA version: 9.1Level: LLTClassification code 10065147Term: Malignant solid tumorMedDRA version: 9.1Level: LLTClassification code 10052399Term: Neuroendocrine tumourMedDRA version: 9.1Level: LLTClassification code 10026664Term: Malignant pancreatic islet neoplasmEUCTR2008-005806-38-FRF.Hoffmann-La Roche Ltd.134
已完成
1 期
A Study of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus (T2DM)Type 2 Diabetes MellitusJPRN-jRCT2051210029Wakayama Naohiko66
已完成
不适用
A rising multiple dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered SCH 900389 in healthy females (P07036)10013356infertilityNL-OMON36461Schering-Plough52
招募中
1 期
A Single- and Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Intravenous Doses of LY3002813Alzheimer DiseaseJPRN-jRCT2080223143Eli Lilly Japan K.K.