ISRCTN98204977已完成1 期
A single and multiple ascending dose study to evaluate the safety, tolerability and PK of ALKS 2680 in healthy subjects and subjects with hypersomnia
Alkermes (United States)0 个研究点目标入组 147 人开始时间: 2022年10月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 147
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
- •Current inclusion criteria as of 11/01/2024:
- •1. Is a healthy male or female aged 18 to 65 years at the time of informed consent.
- •2. Is willing and able to provide informed consent before study participation, as required by local regulations and Independent Ethics Committee (IEC) requirements.
- •3. Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including adherence to contraception requirements.
- •4. Has a body mass index (BMI) =18 and =30 kg/m² at Screening.
- •Parts 4-6 Only
- •6. Has a diagnosis of NT1, NT2, or IH according to ICSD-3 guidelines.
- •7. Has residual EDS (ie, ESS total score >10, referencing the week immediately prior) at Visit 2.
- •8. Is willing and able to discontinue any medications prescribed for the management of narcolepsy or IH symptoms including EDS and/or cataplexy at least 14 days (or 5 half-lives, whichever is longer) prior to Visit 2 to enable sufficient washout and resolution of any withdrawal symptoms.
- •9. Has a BMI =18 and =40 kg/m² at Screening.
- •Previous inclusion criteria:
- •1. Is a healthy male or female aged 18 to 65 years at the time of informed consent.
- •2. Is willing and able to provide informed consent before study participation, as required by local regulations and Independent Ethics Committee (IEC) requirements.
- •3. Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including adherence to contraception requirements.
- •4. Has a body mass index (BMI) =18 and =30 kg/m² at Screening.
排除标准
- •Current exclusion criteria as of 11/01/2024:
- •1. Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Screening.
- •2. Is currently pregnant, breastfeeding, or is planning to become pregnant during the study.
- •3. Does not have a history or presence of any clinically significant (treated or untreated) illness, disease, abnormality, behavioral or psychiatric disorder, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject’s ability to complete the trial.
- •4. Has a positive alcohol breath test or urine drug screen for drugs of potential abuse at In-clinic Admission.
- •5. Has a history or presence at Screening of any clinically significant (treated or untreated) illness, disease, abnormality, behavioral or psychiatric disorder or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject’s ability to complete the trial.
- •6. Has a history or presnce at Screening of any significant cardiovascular disease (eg, myocardial infarction, ischemic heart disease, cardiac failure, arrhythmia).
- •7. Has a corrected QT interval (Fridericia correction; QTcF) >450 milliseconds (msec) if male and >470 msec if female, PR interval >210 msec, or any other ECG finding at Screening or upon admission, confirmed by repeat testing, that, in the opinion of the Investigator, might compromise subject safety.
- •8. Has a history of left bundle branch block or evidence of same on ECG at Screening or Baseline.
- •9. Has persistent systolic BP >[140] or <[90] mmHg or diastolic BP >[90] or <[50] mmHg at Screening or Baseline, or history of orthostatic hypotension.
- •10. Has persistent HR <45 beats/min or >100 beats/min at Screening or Baseline.
- •11. Is employed by Alkermes, the contract research organization (CRO), or study site (permanent, temporary contract worker, or designee responsible for the conduct of the study) or is immediate family (ie, a spouse, parent, sibling, or child, whether biological or legally adopted) of an Alkermes, CRO, or study site employee.
- •12. Consumes more than 400 mg of caffeine (ie, >5 cups of coffee) per day or has substantial changes in caffeine consumption in the 30 days prior to Screening.
- •13. Consumes more than 20 grams of alcohol (ie, >2 standard” drinks in Australia ) per day or has substantial changes in alcohol consumption in the 30 days prior to Screening.
- •14. Consumes nicotine daily (ie, =1 cigarette, vaping or chewing tobacco, nicotine patch or gum) or has substantial changes in nicotine consumption in the 30 days prior to Screening.
- •15. Consumes cannabis or cannabis-derived compounds (eg, marijuana cigarettes, vaping, edibles, beauty and skincare products, or oils containing cannabidiol [CBD] and/or tetrahydrocannabinol [THC]) more than 3 times per month or has substantial changes in cannabis consumption in the 30 days prior to Screening.
- •16. Has a substance use disorder according to Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition; DSM-5) guidelines, including use of alcohol, nicotine, cannabis, narcotics, or any illicit substance.
- •17. Has a positive alcohol breath test or urine drug screen for drugs of potential abuse at In- clinic Admission.
- •18. Has active suicidal ideation or any history of suicidal behavior; or has a Yes” to any of the five yes/no questions on the Colu
研究者
相似试验
已完成
1 期
Phase 1 study of BAY 3283142 in Japanese healthy male participantsChronic kidney diseaseJPRN-jRCT2071230002Myoishi Masafumi36
招募中
1 期
Multiple-Dose, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY3303560 in Patients with Mild Cognitive Impairment due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease (I8G-MC-LMDD)Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's DiseaseJPRN-jRCT2080223501Eli Lilly Japan K.K.
招募中
1 期
A single- and multiple ascending dose study of KP-910 in healthy adult males and healthy elderly males.JPRN-jRCT2071230041Murakami Harumi96
进行中（未招募）
1 期
Single and Multiple Dose Study of MK-0616 in Healthy Japanese ParticipantsHypercholesterolemiaJPRN-jRCT2031210233Tanaka Yoshiyuki48
已完成
1 期
Single and Multiple Dose Study of MK-5475 in Healthy ParticipantsPulmonary HypertensionJPRN-jRCT2031210073Tanaka Yoshiyuki48