NL-OMON52033已完成不适用
A Randomized, Double-Blind, Placebo-Controlled, 2-Way Crossover, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Danavorexton in Healthy Subjects Undergoing Opioid-Induced Respiratory Depression - Takeda - TAK-925-1021 Study
Takeda0 个研究点目标入组 16 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
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
- 年龄范围
- 18 至 64（—）
入选标准
- •1. In the opinion of the investigator, the subject is capable of understanding
- •and complying with protocol requirements.
- •2. The subject reviews, and signs and dates an informed (electronic) consent
- •form, in addition to any required privacy authorization, before the initiation
- •of any study procedure.
- •3. The subject is male and aged 18 to 55 years, inclusive, at the screening
- •4. The subject is a current nonsmoker who has not used tobacco- or
- •nicotine-containing products (eg, nicotine patch) for at least 6 months before
- •the administration of the study drug.
- •5. The subject has regular sleep-wake habits (eg, routinely spends 6.5 to 9
- •hours in bed nightly) and regularly goes to bed between 9:00 PM and 1:00 AM, as
- •determined by investigator interviews.
- •6. A male subject must meet the following birth control requirements:
- •a) For a male subject who is sterile: no restrictions are required for a
- •vasectomized male subject, provided the subject is at least 1-year
- •postbilateral vasectomy procedure before the first dose of the study drug. If a
- •vasectomy procedure was performed less than 1 year before the first dose of the
- •study drug, the male subject must follow the same restrictions as a male that
- •has not had a vasectomy/sterilization (below). Appropriate documentation of
- •surgical procedures should be provided.
- •b) For a male subject who is nonsterilized: if sexually active with a female
- •partner of childbearing potential, the subject must agree to use an appropriate
- •method of contraception, including a condom with or without spermicidal cream
- •or jelly. These precautions will begin from the administration of the study
- •drug until 5 half-lives plus 90 days after the administration of the study drug.
- •c) Male subjects must agree to not donate sperm from the time of study drug
- •administration until 5 half lives plus 90 days after the administration of the
- •study drug.
- •7. The subject has a BMI >=18 and <=32 kg/m2 at the screening visit.
- •8. The subject must be judged to be in good health based on results of safety
- •laboratory tests (biochemistry, hematology, and urinalysis testing) performed
- •at the screening visit and on medical history, physical examination, vital-sign
- •measurements, and 12-lead ECG performed at screening and baseline assessments.
- •9. The subject has no history of hypertension or use of antihypertensive
- •medication. BP must be <140 mmHg (systolic) and <90 mmHg (diastolic); subjects
- •will have a heart rate within the range of 50 to 90 beats per minute at the
- •screening visit. BP will be averaged over 3 readings that are done 10 minutes
- •10. The subject agrees to refrain from taking excluded medications, vitamins,
- •supplements or dietary products listed in Section 7.3 of the protocol during
排除标准
- •- The subject has received treatment with another investigational drug within 3
- •months before screening, or the subject participated in more than 4
- •investigational drug studies within 1 year before screening.
- •- The subject received immunotherapy within the past year.
- •- The subject has facial hair that could interfere with the seal of a facemask
- •(per investigator or site staff judgment), and is unwilling to shave it off
- •before check-in.
- •- The subject has a positive test result for hepatitis B surface antigen, HCV,
- •HIV antibody/antigen, or syphilis serum reaction test at screening. Note:
- •subjects with positive HBV or HCV serology may be enrolled if quantitative
- •polymerase chain reaction for HBV or HCV viral RNA is negative.
- •- The subject has a risk of suicide according to endorsement of Item 4 or 5 of
- •the C-SSRS at the screening visit or has made a suicide attempt in the previous
- •- The subject has a positive alcohol or drug screen at screening or check-in,
- •has a history of alcohol consumption exceeding 2 standard drinks per day on
- •average within the 12 months before screening, or has a history of opioid abuse.
- •- The subject has caffeine consumption of more than 400 mg/day for 2 weeks
- •before screening (1 serving of coffee is approximately equivalent to 100 mg of
- •- The subject has a screening ECG with a QT interval with Fridericia correction
- •method (QTcF) >450 ms.
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