NL-OMON20667尚未招募不适用
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALKS 6610 with a Pilot Evaluation of Food Effect in Healthy Adult Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
研究概览
简要总结
A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Signed informed consent prior to any study-mandated procedure
- •2. Ability to communicate well with the Investigator in the Dutch language and willing to follow the procedures and comply with study restrictions as outlined in the protocol
- •3. Male or female age =18 years and =60 years old at the time of informed consent
- •4. Body mass index (BMI) =18 and <30 kg/m2 at Screening
排除标准
- •1. Clinically significant illness or disease within 8 weeks of dosing, or any clinically abnormal symptom or organ impairment, found by medical history, physical examinations, vital signs, electrocardiogram (ECG) finding, or either abnormal laboratory values or laboratory test results at Screening or Baseline
- •2. Females who are breastfeeding or pregnant at Screening or Baseline
- •3. Females of childbearing potential. NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically
- •4. A prolonged QT/QTc interval (QTcF >450 ms in males, and QTcF >470 ms in females) demonstrated on ECG at Screening or Baseline
- •5. History of clinically significant arrhythmia or uncontrolled arrhythmia
- •6. Positive Hepatitis A antibodies (HAV IgM), Hepatitis B surface antigen (HBsAg), Hepatitis B antibodies (Anti-HBc), Hepatitis C antibodies (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at Screening
- •7. Use of nicotine containing products within 2 weeks before the first dose of study drug (Day 1)
- •8. Use of prescription and non-prescription medications, herbal and nutritional supplements within 2 weeks prior to dosing or 5 half-lives, whichever is longer.
- •9. Any history of lifetime suicidal ideation or behaviour, confirmed by a Columbia Suicide Severity Rating Scale (C-SSRS) response of Yes” to questions 4 or 5 at Screening
- •10. Currently enrolled in another clinical study, used any investigational drug or device within 3 months prior to dosing, or having participated in more than 4 investigational drug studies within 1 year prior to Screening
- •11. Additional criteria may apply
研究者
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