NCT02055300已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of LY03005
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of escalating single oral doses of LY03005 in healthy subjects and to characterize the pharmacokinetics (PK) of escalating single oral doses of LY03005.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are capable of giving informed consent and complying with study procedures;
- •Are between the ages of 18 and 45 years, inclusive;
- •Female subjects have a negative pregnancy test result prior to enrollment, and meet the following criteria defined as:
- •If child-bearing potential, agree to avoid pregnancy during the study and one month after the end of the study by using at least one effective contraceptive method(s), such as an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives used for at least one month prior to screening, injectable progesterone, or progesterone sub-dermal implants.
- •Surgically sterile for at least 3 months prior to screening by one of the following means:
- •Bilateral tubal ligation
- •Salpingectomy (with or without oophorectomy)
- •Surgical hysterectomy
- •Bilateral oophorectomy (with or without hysterectomy)
- •Postmenopausal, defined as one of the following:
- •Last menstrual period greater than 12 months prior to screening
- •Considered healthy by the Principal Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs;
- •Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6 months before screening;
- •Body mass index (BMI) of 19 to 32 kg/m2 inclusive and body weight not less than 50 kg;
- •Willing and able to adhere to study restrictions and to be confined at the clinical research center.
排除标准
- •Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
- •Subjects with a mean systolic blood pressure of three measurements >130 mmHG, or a mean diastolic blood pressure of three measurements >90 mmHG at screening.
- •History or presence of malignancy other than adequately treated basal cell skin cancer
- •Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
- •A history of seizure. However, a history of febrile seizure is allowed;
- •Positive pregnancy test result, or plan to be pregnant if female;
- •A hospital admission or major surgery within 30 days prior to screening;
- •Participation in any other investigational drug trial within 30 days from the last dosing of other trials to screening;
- •A history of prescription drug abuse, or illicit drug use within 6 months prior to screening;
- •A history of alcohol abuse according to medical history within 6 months prior to screening;
- •A positive screen for alcohol, drugs of abuse;
- •Tobacco use within 6 months prior to screening;
- •An unwillingness or inability to comply with food and beverage restrictions during study participation;
- •Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or blood products) or acute loss of blood during the 90 days prior to screening;
- •Use of prescription or over-the-counter (OTC) medications, and herbal (including St John's Wort, herbal teas, garlic extracts)within 14 days prior to dosing (Note: Use of acetaminophen at < 3g/day is permitted until 24 hours prior to dosing);
- •A history of intolerance or hypersensitivity to venlafaxine or desvenlafaxine or any excipients;
- •Patients with a history of suicide attempt in the past 6 months and/or seen by the investigator as having a significant history of risk of suicide or homicide;
- •An unwillingness of male participants to use appropriate contraceptive measures if engaging in sex intercourse with a female partner of childbearing potential. Appropriate measures include use of a condom and spermicide and, for female partners, use of an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, progesterone sub-dermal implants, or a tubal ligation. Sexual intercourse with pregnant or lactating women is prohibited.
研究组 & 干预措施
LY03005 - 20
Experimental
LY03005 Dose Strength 20mg
干预措施: LY03005 (Drug)
LY03005 - 20
Experimental
LY03005 Dose Strength 20mg
干预措施: Placebo (Drug)
LY03005 - 40
Experimental
LY03005 Dose Strength 40mg
干预措施: LY03005 (Drug)
LY03005 - 40
Experimental
LY03005 Dose Strength 40mg
干预措施: Placebo (Drug)
LY03005- 80
Experimental
LY03005 Dose Strength 80mg
干预措施: LY03005 (Drug)
LY03005- 80
Experimental
LY03005 Dose Strength 80mg
干预措施: Placebo (Drug)
LY03005 - 120
Experimental
LY03005 Dose Strength 120mg
干预措施: LY03005 (Drug)
LY03005 - 120
Experimental
LY03005 Dose Strength 120mg
干预措施: Placebo (Drug)
LY03005 - 160
Experimental
LY03005 Dose Strength 160 mg
干预措施: LY03005 (Drug)
LY03005 - 160
Experimental
LY03005 Dose Strength 160 mg
干预措施: Placebo (Drug)
LY03005 - 200
Experimental
LY03005 Dose Strength 200mg
干预措施: LY03005 (Drug)
LY03005 - 200
Experimental
LY03005 Dose Strength 200mg
干预措施: Placebo (Drug)
LY03005 - 120 - Fed
Experimental
LY03005 120mg under Fed Conditions
干预措施: LY03005 (Drug)
LY03005 - 120 - Fed
Experimental
LY03005 120mg under Fed Conditions
干预措施: Meal (Other)
Pristiq
Active Comparator
Pristiq - 50mg
干预措施: Pristiq (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 11 Days
次要结局
- PK parameters of: Cmax,(4 days)
研究者
研究点 (1)
Loading locations...
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