ACTRN12615001025527终止1 期
A Phase 1, Five-Period, Randomized, Placebo-Controlled, Double- Blinded, Single Center, Single, Ascending-Dose Study to Assess the Safety and Pharmacokinetics of ZYN002 Administered as a Transdermal Gel to Healthy Subjects and Patients with Epilepsy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 44
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
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Healthy male or female adults, 18-55 years of age,
- •2. Judged by the investigator to be in generally good health at screening based upon the results of a medical history, physical examination, 12-lead ECG, and clinical laboratory test results.
- •3. Patients enrolled in Part 2 must have a diagnosis of epilepsy with partial onset seizures that is stable. Currently seizure-free or controlled on one or two antiepileptic drugs [AEDs] with a monthly seizure frequency of less than 5 seizures per month. The patient should have had the diagnosis for at least one year which has been documented by review of the most informative electroencephalogram (EEG), scan (either computed tomography [CT] or magnetic resonance imaging [MRI]), and narrative, including detailed descriptions of each seizure type from the physician who manages the patient’s epilepsy. The historical baseline of seizures over the previous 8 weeks should show a reasonably stable pattern of seizure occurrence without clustering of seizures.
- •4. Patients enrolled in Part 2 must be on a stable dose (no changes in AED regimen for the 4 weeks preceding study enrollment) of no more than two approved AEDs limited to: gabapentin, lamotrigine, levetiracetam, pregabalin, topiramate, lacosamide, and zonisamide. Patients must remain on a stable AED dose regimen throughout the study.
- •5. Subject/patient has a body mass index between 18-30 kg/m2.
- •6. Females of childbearing potential, must have a negative urine pregnancy test at the Screening Visit and a negative urine pregnancy prior to study treatment.
- •7. Subject/patient agrees to abide by all study restrictions and comply with all study procedures.
- •8. Subject/patient must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.
- •9. In the investigator’s opinion, the subject/patient is reliable and is willing and able to comply with all protocol requirements and procedures (including keeping an accurate diary of seizures, scheduled visits and confinement periods).
排除标准
- •1. Females who are pregnant, nursing or planning a pregnancy; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 21 days prior to the first dose of study medication and for 28 days after the last dose of study medication.
- •a. Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, vasectomy, intrauterine device.
- •2. Patients with epilepsy enrolled in Part 2 cannot have a history of status epilepticus or the occurrence of seizure clusters (bouts of seizures so close together that an accurate seizure counts are not possible).
- •3. Use of tobacco/nicotine-containing products within one month of Screening Visit or during study.
- •4. Use of the following AEDs: phenytoin, carbamazepine, phenobarbital, oxcarbazepine and valproate, valproic acid, tiagabine, ethosuximide, clobazam, clonazepam, or vigabatrin.
- •5. Use of any prescription drugs except hormonal contraception and AEDs (for patients in Part 2), or herbal supplements within four weeks prior to Screening or any over-the-counter (OTC) drugs/vitamins within 72 hours prior to first dose of study medication through the End of Study Visit.
- •6. Use of cannabis or any cannabidiol (CBD)-containing product within four weeks of the Screening Visit or during the study.
- •7. Positive result for the presence of Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibodies (HCVAb), or human immunodeficiency virus (HIV) antibodies.
- •8. Positive drug screen, for ethanol, cocaine, delta-9-tetrahydrocannabinol (THC), barbiturates, amphetamines, benzodiazepines (except clonazepam when prescribed as an AED medication), and opiates.
- •9. Any clinically significant condition or abnormal findings at the Screening Visit that would, in the opinion of the investigator, preclude study participation or interfere with the evaluation of the study treatment.
- •10. Any skin disease or condition, including eczema, psoriasis, melanoma, acne or contact dermatitis, scarring, imperfections, lesions, tattoos or discoloration that may affect treatment application, application site assessments, or affect absorption of the study drug.
- •11. Use of cosmetics or lotions on the shoulder/upper arms during the study.
- •12. History of significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any adhesives, compound, or chemical class related to ZYN002 or its excipients.
- •13. Has taken caffeine or xanthine products within 24 hours of dosing. Has taken grapefruit products within the last four weeks or during the study.
- •14. History of treatment for, or evidence of alcohol or drug abuse within the past year or regular alcohol consumption exceeding an average of two units of alcohol per day.
- •15. History or current diagnosis of a significant psychiatric disorder that would, in the opinion of the investigator, affect the subject’s ability to comply with the study requirements.
- •16. Has suspected or confirmed cardiovascular disease.
- •17. Participation in any investigational product or device study within 30 days prior to Screening Visit, or is scheduled to participate in an investigational device or another investigational drug study during the course of this study.
- •18. Demonstrates behavior indicating unreliability or inability to comply with the requirements of the proto
研究者
相似试验
进行中（未招募）
不适用
A Randomized, Single-Blind, Placebo-Controlled, Phase 2 Trial of the Safety, Immunogenicity, and Tolerability of Meningococcal Serogroup B (MnB) rLP2086 Vaccine at Doses of 60 µg, 120 µg, and 200 µg in Healthy Adolescents Aged 11 to 18 YearsThe test is a vaccine. The subjects are healthy adolescents.MedDRA version: 14.1Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestationsEUCTR2008-007789-51-PLPfizer Inc715
进行中（未招募）
不适用
A clinical study to test the safety and immune response of a vaccine against a bacteria causing meningitis B at doses of 60 µg, 120 µg, and 200 µg in healthy adolescents aged 11 to 18 YearsPrevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MnB) in adolescents and young adults, aged 10 through 25 years.MedDRA version: 17.1Level: LLTClassification code 10004049Term: Bacterial meningitisSystem Organ Class: 100000004862EUCTR2008-007789-51-Outside-EU/EEAWyeth Research Division of Wyeth Pharmaceuticals Inc.539
已完成
1 期
To evaluate safety and tolerability after multiple oral doses of AZD1656 in type 2 diabetes patients on top of metformiCTRI/2009/091/000774AstraZeneca AB, 151 85 Södertälje, Sweden24
Unknown
2 期
A clinical Study to assess the Efficacy and Safety of Ursodiol Injection in covid-19 patientsCTRI/2021/11/038307Shilpa Medicare Limited16
进行中（未招募）
不适用
Safety and Efficacy Study of DGLA Cream in Patients with Atopic DermatitisAtopic DermatitisEUCTR2012-003739-44-FIDignity Sciences Limited200