NCT06198686已完成1 期
An Evaluation of The Absolute Bioavailability of TH104
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
- 20
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration Versus Time Curve (AUC) of Nalmefene
研究概览
简要总结
This is a single-dose, single-center, open-label, randomized, 2-way crossover study (2 treatments, 2 periods and 2 sequences) of a buccal formulation of Nalmefene 16 mg and a 1 mg intravenous dose of nalmefene injection, with a least 7 days washout period between doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject age between 18 to 55 years old.
- •Subject body weight ≤ 120 kg, with a BMI within of 18-30 kg/m2
- •Subject is able to complete the clinical study including the follow-up.
- •Subject is capable of providing written informed consent.
排除标准
- •Breastfeeding female.
- •Positive pregnancy test (female).
- •Systolic blood pressure outside 80-140 mm Hg or diastolic blood pressure outside 50-80 mm Hg.
- •Bradycardia defined as symptomatic heart rate < 60 bpm or asymptomatic heart rate < 55 bpm and tachycardia defined as resting heart rate > 100 bpm.
- •Clinically significant ECG abnormalities.
- •QTc > 450 ms for male and > 460 ms for female.
- •A history of allergies, or any significant adverse reactions, to any medications.
- •A history of seizures or convulsions.
- •Clinically significant medical, familial, or surgical history of eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, genitourinary, neurological, hematopoietic, lymphatic, endocrine, metabolic, dermatological, musculoskeletal, psychological and/or other major disease or malignancy.
- •Family history of sudden cardiac death.
- •Clinically significant physical examination finding.
- •Clinically significant laboratory abnormalities.
- •Hemoglobin < 12.0 g/dL for male and < 11.0 g/dL for female at screening.
- •Creatinine clearance <90 mL/m2/min
- •Total bilirubin , ALT/AST greater than upper limit of normal, or CPK > 2 x upper limit of normal.
- •Hepatitis B, Hepatitis C or HIV positive.
- •Positive test for drugs of abuse.
- •Smoke more than 10 sticks of cigarettes a day, vape more than 20 mg of liquid nicotine a day, or equivalent.
- •A history of drug or substance abuse, including alcohol (≥ 7 units per week) within 6 months before dosing (1 unit of alcohol equals approximately ½ pint [240 mL] of beer, 1 glass [125 mL] of wine, or 1 shot [25 mL] of spirit).
- •Have taken any medications (including herbal remedies) within 7 days before dosing, with the exception of birth control medications and other medications deemed acceptable by the Investigator.
- •Use of any opioid antagonist (e.g., naloxone, naltrexone, nalmefene) in the past.
- •Clinically significant illness or injury or hospitalization for any reason within 28 days before dosing.
- •Participation in other clinical study involving a marketed or investigational drug within 28 days or 10 half-lives of the drug before dosing, whichever is longer.
- •Donation of > 500 mL of plasma within 14 days before dosing; or donation or loss of whole blood (excluding the amount of blood collected during screening) before dosing as follows:
- •50-300 mL within 28 days,
- •301-500 mL within 42 days, or
- •500 mL within 84 days.
- •Any other medical condition or reason that, in the opinion of the Investigator or Research Physician, makes the subject unsuitable to participate in the clinical study.
- •Female of childbearing potential having unprotected sexual intercourse with any non-sterile male partner within 14 days before dosing and until 60 days after receiving the last dose; acceptable methods of contraception include:
- •double barrier (1 by each partner), and at least 1 of these barriers (condom, cervical cap, diaphragm or sponge) must contain spermicide,
- •hormonal (oral, injectable, transdermal, intravaginal or implantable),
- •intrauterine contraceptive system,
- •surgical (vasectomy or tubal ligation), or
- •sexual abstinence.
研究组 & 干预措施
Sequence 2
Experimental
A 1 mg intravenous dose of nalmefene injection, and a buccal formulation of Nalmefene 16 mg with a least 7 days washout period between dose
干预措施: Nalmefene (Drug)
Sequence 1
Experimental
A buccal formulation of Nalmefene 16 mg and a 1 mg intravenous dose of nalmefene injection, with a least 7 days washout period between dose
干预措施: Nalmefene (Drug)
结局指标
主要结局
Area Under the Plasma Concentration Versus Time Curve (AUC) of Nalmefene
时间窗: 4 days
Determine the absolute bioavailability of a buccal dose of TH104
次要结局
- Number of Participants With Treatment-Related Adverse Events(4 days)
研究者
研究点 (1)
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