ACTRN12613000085774已完成1 期
An open label, single dose, phase I pilot study in healthy volunteers to determine the pharmacokinetic, safety and tolerability profiles of oxymorphone delivered from a transdermal oxymorphone patch to promote pain relief.
Phosphagenics Limited0 个研究点目标入组 12 人开始时间: 2013年1月23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
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- Male
入选标准
- •* Participant is free from clinically significant illness or disease
- •*BMI is equal to or greater than 19 and is equal to or less than 27 kg/m2
- •* Weight > 50kg at Screening.
- •* Adequate venous access in both arms for collection of a number of blood samples.
- •* Male participants that are not surgically sterile (i.e. vasectomy) must be abstinent or agree to use effective barrier contraception (i.e., condom) during the study period.
排除标准
- •* Evidence of clinically significant impairment/disorders.
- •* History of coronary disease, peripheral vascular disease, cerebrovascular accident, transient ischaemic attack, uncontrolled hypertension or signs/symptoms of ischaemic heart disease.
- •* Have a seated systolic blood pressure of < 90 mmHg or >160 mmHg and/or diastolic blood pressure of < 50 mmHg or >95 mmHg at Screening or Check-In.
- •* History of acute or severe bronchial asthma, diagnosed obstructive sleep apnoea, hypoxia, hypoxaemia, hybercarbia, or other obstructive airway disease or any condition that may increase the risk for respiratory depression.
- •* A resting (seated for at least five minutes) pulse rate at rest of < 45 BPM or > 100 BPM at Screening or Check-In.
- •* History of neurologic conditions such as seizures or convulsive disorders (including epilepsy), severe head injury or increased intracranial pressure.
- •* A calculated creatinine clearance of < 85 mL/minute.
- •* Have undergone surgery or received anaesthetic within 30 days of Day 1.
- •* Use of CNS depressants including: other opioids, sedative, anxiolytics, hypnotics, neuroleptics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines or cimetidine within 30 days of Day 1.
- •* Use of macrolide antibiotics (e.g., Erythromycin), azole antifungal agents (e.g., Ketoconazole) or protease inhibitors (e.g., Ritanovir) within 30 days of Day 1.
- •* Use of any prescription medication during the 14 days prior to Day 1 and for duration of study, unless approved by both the PI and the Medical Monitor (in writing).
- •* Use of any OTC product, herbal product, diet aid, or hormone supplement, within 14 days prior to Day 1 and for duration of study.
- •* Known intolerance, allergy or hypersensitivity reactions to naltrexone, naloxone, oxymorphone, opioid analgesics, or any commercially available adhesives.
- •* Any history of a dermatological condition or recurrent generalised skin disorder within the last 5 years including psoriasis and eczema or any other skin condition.
- •* Any tattoos, bruises, scars or skin lesions on the area where the IP is to be applied which may interfere with study assessments.
- •* Positive screening test for HIV antibodies, Hepatitis B surface antigen or Hepatitis C antibody.
- •* Evidence or history of substance or alcohol abuse (drink more than 2 standard units of alcohol per day), including positive test results for drugs of abuse in the urine or a positive alcohol breath test at Screening or at Check-In.
- •* Unwilling or unable to abstain from recreational drug/substance use, alcohol, caffeine or other xanthine-containing products from Day -1 until discharge.
- •* Participants who are not willing to refrain from smoking 48 hours before Day –1 until discharge.
- •* Consumption of grapefruit, grapefruit juice or any products containing CYP3A4 inhibitors and inducers within 14 days of Day 1 and through to completion of the confinement period.
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