ACTRN12624000898550尚未招募1 期
A Phase 1, Double Blind, Randomized, Placebo Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Doses of SEP-786 in Healthy Adult Participants (SEP-786 Phase 1 SAD and MAD)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 180
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 24 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Are 24 through 55 years of age, inclusive, at the time of signing the informed consent
- •2. Are overtly healthy, as determined by medical evaluation, including medical history, physical examinations, laboratory profiles, vital signs, and 12 lead ECGs
- •3. Have clinical laboratory test values within the normal range, unless assessed by the investigator or designee as a clinically nonsignificant value, with repeat laboratory tests permitted if necessary to make decisions
- •4. Have a body weight within the range of greater than or equal to (>=) 50 kilogram (kg) and less than or equal to (<=) 90 kg and body mass index (BMI) within the range of >=18.5 to <=27.0 kilogram per square meter (kg/m^2)
- •5. Have an estimated glomerular filtration rate (eGFR) >=90 milliliter per minute (mL/min)
- •Note: eGFR is estimated by the chronic kidney disease epidemiology collaboration (CKD EPI) equation
- •6. Have a QT interval corrected by Fridericia’s method (QTcF) <=450 millisecond (ms) for assigned male at birth (AMAB) participants and <=470 ms for assigned female at birth (AFAB) participants at screening
- •7. Have inorganic phosphorus and/or serum calcium (albumin corrected) within normal limits at screening and Day -2, unless assessed by the investigator as a clinically insignificant value
- •8. Are willing and able to abstain from drug, alcohol, and tobacco from Day -2 until discharge from the clinical research unit (CRU)
- •9. Have negative urine drug and breath alcohol results at screening and Day -2
排除标准
- •1.Have a history or presence of any of the following:
- •a.Malignant disease, other than basal cell epithelioma/carcinoma or completely resected squamous skin cancer with no recurrence for 12 months
- •b.Diabetes mellitus
- •Note: a history of gestational diabetes that is fully resolved is permitted.
- •c.Hyperparathyroidism, hypoparathyroidism, hypercalcemia, hypercalciuria, kidney stones, familial benign hypocalciuric hypercalcemia, osteomalacia, Paget’s disease, osteoporosis, or any type of metabolic bone disease or radiation therapy to the skeleton
- •d.Cardiac dysfunction, including abnormal echocardiogram left ventricular ejection fraction (LVEF) <50%, congestive heart failure, long QT syndrome, valvular heart disease except clinically insignificant mitral valve prolapse, hypertrophic cardiomyopathy, or cardiovascular disease
- •e.Cerebrovascular disease
- •f.Thromboembolic events or ischemic heart disease
- •g.Alcoholism or drug abuse within the past 1 year
- •Note: Alcohol abuse is considered >14 standard drinks/week in AFAB potential participants and >21 standard drinks/week in AMAB potential participants.
- •h.Stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- •i.Clinically significant medical or psychiatric condition or disease in the opinion of the principal investigator or designee
- •j.Hepatitis B (defined as HBsAg reactive) or hepatitis C (defined as HCV antibody–positive) at screening
- •k.Human immunodeficiency virus (HIV) positive status (participants to be screened for HIV or provide a recent negative test)
- •2.Have an acute disease state (eg, nausea, vomiting, fever, diarrhea) within 7 days of the first dose of study intervention
- •3.Have a positive COVID 19 polymerase chain reaction (PCR) test at admission
- •4.Are unable to refrain from using or anticipate the use of any drug or medical device, including prescription and over the counter (OTC) medications, nutritional or dietary supplements, recreational drugs, herbal preparations, or vitamins, from Day -7 until follow up visit, or as specified below:
- •a.From Day -28 for significant inhibitors or inducers of CYP enzymes and/or P gp, including St. John’s wort, to discharge from CRU
- •b.From Day -42 for PPIs, supplements containing calcium (Ca) or magnesium (Mg) (including Tums®), and H2 antagonists until discharge from CRU
- •Exceptions:
- •a.Acetaminophen, which may be used at doses of 1 gram or less per day until 24 hours prior to check in
- •b.OTC nonsteroidal anti inflammatory drug (NSAIDs), which may be used until 24 hours prior to check in
- •c.OCPs or an intrauterine device (IUD) or intrauterine hormone releasing system (IUS)
- •d.Any drug approved by the medical monitor
- •5.Have participated in another clinical study within 28 days prior to the first dose of study drug or at least 5.5 half lives, based on the t1/2 for the investigational drug, whichever is longer. The 28 day window is derived from date of the previous study’s last scheduled blood collection or dosing, whichever was later, to Day 1 of the current study.
- •6.Have clinically significant abnormalities on clinical laboratory results (including hematology, chemistry, and urinalysis) at screening and Day -2
- •7.Have evidence of endocrine alterations of calcium/phosphate/PTH homeostasis at screening
- •8.Have donated blood within 7 days of the first dose of study intervention or have had significant (ie, >=500 mL) blood loss within 8 weeks
研究者
相似试验
已完成
1 期
Assessment of the trial drugs ACH-0143102 and ACH-0142684, when taken by healthy men and women.ACTRN12614000102673Achillion Pharmaceuticals, Inc36
已完成
1 期
A Phase-I Clinical Trial to study the Safety and efficacy of Bharat Biotech International Limited Influenza A H1N1 pandemic 2009 Vaccine (Inactivated) in healthy volunteers.CTRI/2010/091/000152Bharat Biotech International Limited160
已完成
不适用
A Phase 1, Randomized, Double blind, Placebo Controlled, Single and Multiple Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX 152 Alone and in Combination with VX 661/Ivacaftor, and Bioavailability and Food Effect of VX 152 in Healthy Adult Subjectscystic fibrosis10038686NL-OMON43756Vertex Pharmaceuticals120
撤回
1 期
EmtinB Safety, Tolerability and Pharmacokinetics (PK) Study in Healthy Participantseurodegenerative disordersNeurodegenerative disordersNeurological - Neurodegenerative diseasesACTRN12622001019796euroScientific Biopharmaceuticals Ltd72
已完成
不适用
A Phase 1, Randomized, Double-Blind, Placebo Controlled, Single Dose Escalation Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Migalastat Hydrochloride given Intravenously to Healthy Volunteers with an Open-Label, Randomized, Two-Way Crossover ArmFabry disease10083624lysosomal storage diseaseNL-OMON40853Amicus Therapeutics, Inc.31