A Randomized, Double-blind, Triple-dummy, Placebo Controlled, Single-dose, 4-way Crossover Study To Determine The Relative Abuse Potential Of Pf-00345439 (Oxycodone Extended Release Capsules) Compared To Immediate-release Oxycodone And Placebo When Administered Orally Whole And/or Chewed To Non-dependent, Recreational Opioid Users Under Fasted Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- High: Peak Effect (Emax)
研究概览
简要总结
This study will determine the relative abuse potential of intact and chewed PF-00345439 (Oxycodone Extended-Release Capsules) compared to crushed oxycodone HCL immediate release (IR) tablets and placebo administered orally to non-dependent, recreational opioid users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Healthy male and/or female subjects between the ages of 18 and 55 years who are recreational opioid users and are NOT dependent on opioids.
排除标准
- •Evidence or history of clinically significant medical conditions.
- •Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine).
- •Has participated in, is currently participating in, or is seeking treatment for substance-and/or alcohol-related disorders (excluding nicotine and caffeine).
- •Has a positive urine drug screen (UDS) excluding tetrahydrocannabinol (THC).
- •Has a positive alcohol breath test.
- •Has any history of a condition in which an opioid is contraindicated.
- •History of sleep apnea in the past 5 years that has not been resolved or corrected.
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results .
- •Positive test for Hepatitis B, Hepatitis C, or HIV.
- •Allergy or history of hypersensitivity to naloxone HCl, oxycodone HCl, other opioids, and/or lactose.
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
研究组 & 干预措施
Treatment A
Placebo solution +placebo capsule + placebo capsule chewed.
干预措施: Capsule (Drug)
Treatment B
PF-00345439 taken whole + placebo solution + placebo chewed
干预措施: PF-00345439 (Drug)
Treatment C
PF-00345439 chewed + placebo solution + placebo taken whole
干预措施: PF-00345439 (Drug)
Treatment D
Oxycodone HCl immediate-release 40 mg tablets (eg, 2 x 5 mg + 1 x 30 mg) + placebo taken whole + placebo chewed
干预措施: oxycodone (Drug)
结局指标
主要结局
High: Peak Effect (Emax)
时间窗: 12 hours
High assesses the degree that a subject feels a good effect (ie euphoria) at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar scale); where 0 mm = Not at all and 100 mm = Extremely.
Drug Liking: Peak Effect (Emax)
时间窗: 12 hours
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar visual analogue scale (VAS); where 0 mm = Not at all and 100 mm = Extremely.
Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours
时间窗: 2 hours
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar visual analogue scale (VAS); where 0 mm = Not at all and 100 mm = Extremely.
High: Area Under Effect Curve (AUE) From 0-2 Hours
时间窗: 2 hours
High assesses the degree that a subject feels a good effect (ie euphoria) at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar scale); where 0 mm = Not at all and 100 mm = Extremely.
次要结局
- Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour(1 hour)
- Chewing Duration(5 min)
- Good Drug Effects: Area Under Effect Curve (AUE) From 0-12 Hours(12 hours)
- Overall Drug Liking(24 hours)
- Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-12 Hours(12 hours)
- High: Area Under Effect Curve (AUE) From 0-1 Hour(1 hour)
- Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour(1 hour)
- Bad Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours(2 hour)
- Feeling Sick: Area Under Effect Curve (AUE) From 0-12 Hours(12 hours)
- Nausea: Area Under Effect Curve (AUE) From 0-3 Hours(3 hours)
- Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours(2 hours)
- Feel Sick: Peak Effect (Emax)(12 hours)
- Sleepy: Peak Effect (Emax)(12 hours)
- Dizzy: Peak Effect (Emax)(12 hours)
- Take Drug Again Effect at 24 Hours(24 hours)
- Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-1 Hour(1 hour)
- Taste: Subjective Experience from Chewing(5 min)
- Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours(2 hours)
- Pupillometry: Area Under Effect Curve (AUE) From 0-3 Hours(3 hours)
- High: Area Under Effect Curve (AUE) From 0-3 Hours(3 hours)
- High: Area Under Effect Curve (AUE) From 0-12 Hours(12 hours)
- Feeling Sick: Area Under Effect Curve (AUE) From 0-1 Hour(1 hour)
- Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-2 Hours(2 hours)
- Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours(12 hours)
- Good Drug Effects: Area Under Drug Effect Curve (AUE) From 0-1 Hour(1 hour)
- Good Drug Effects: Area Under Effect Curve (AUE) From 0-3 Hours(3 hours)
- Bad Drug Effects: Area Under Effect Curve (AUE) From 0-12 Hours(12 hours)
- Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour(1 hour)
- Dizzy: Area Under Effect Curve (AUE) From 0-3 Hours(3 hours)
- Nausea: Time to Maximum (Peak) Effect (TEmax)(12 hours)
- Maximum Observed Plasma Concentration (Cmax)(24hr)
- Any Drug Effects: Area Under Drug Effect Curve (AUE) From 0-3 Hours(3 hours)
- Good Drug Effects: Area Under Effect Curve (AUE) From 0-2 Hours(2 hours)
- Bad Drug Effects: Area Under Effect Curve (AUE) From 0-3 Hours(3 hours)
- Feeling Sick: Area Under Effect Curve (AUE) From 0-3 Hours(3 hours)
- Nausea: Area Under Effect Curve (AUE) From 0-2 Hours(2 hours)
- Sleepy: Area Under Effect Curve (AUE) From 0-3 Hours(3 hours)
- Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours(12 hours)
- Feeling Sick: Area Under Effect Curve (AUE) From 0-2 Hours(2 hours)
- Nausea: Area Under Effect Curve (AUE) From 0-1 Hour(1 hour)
- Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour(1 hour)
- Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours(2 hours)
- Sleepy: Area Under Effect Curve (AUE) From 0-12 Hour(12 hours)
- Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour(1 hour)
- Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)(12 hours)
- Pupillometry: Time to Maximum (Peak) Effect (TEmax)(12 hours)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(24hr)
- Area under the curve (AUC)(24hr)
- Nausea: Area Under Effect Curve (AUE) From 0-12 Hours(12 hours)
- Nausea: Peak Effect (Emax)(12 hours)
- Pupillometry: Peak Effect (Emax)(12 hours)
- Drug Liking: Area Under Effect Curve (AUE) From 0-12 Hours(12 hours)
- Texture: Subjective Experience from Chewing(5 mins)
- Half-Life (t1/2)(24 hours)
- Bad Effects: Peak Effect (Emax)(12 hours)
- Good Drug Effects: Peak Effect (Emax)(12 hours)
- Drug Liking: Area Under Effect Curve (AUE) From 0-3 Hours(3 hours)
- High: Time to Maximum (Peak) Effect (TEmax)(12 hours)
- Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)(12 hours)
- Feel Sick: Time to Maximum (Peak) Effect (TEmax)(12 hours)
- Sleepy: Time to Maximum (Peak) Effect (TEmax)(12 hours)
- Dizzy: Time to Maximum (Peak) Effect (TEmax)(12 hours)
- Any Drug Effects: Peak Effect (Emax)(12 hours)
- Drug Liking: Time to Maximum (Peak) Effect (TEmax)(12 hours)
- Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)(12 hours)
- Systemic Clearance (CL)(24hr)
- volume of distribution (Vd)(24hr)