A Phase 1, Open-Label, Randomized, Parallel Dose Group Study to Assess the Pharmacokinetics of Mirabegron OCAS Formulations With Different Release Rates Versus IV Infusion in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 91
- 主要终点
- Characterize the pharmacokinetic profile of 3 doses of oral mirabegron formulations with three different release rates vs. three doses of mirabegron administered intravenously
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetics of three doses of oral mirabegron formulations with three different release rates versus three doses of mirabegron administered intravenously; to study safety and side effects of the oral and IV doses of mirabegron.
详细描述
Subjects will be randomly assigned to one of three oral mirabegron doses and then randomly assigned to one of three oral mirabegron doses and then randomly assigned to one of six treatment sequences.
For all subjects the first treatment will be a reference IV dose. Treatments 2, 3, and 4 will be a random order of slow, fast and target release oral doses of mirabegron. Treatment 5 will be a target release dose of mirabegron from a different batch.
There will be at least 10 day washout between dose administrations.
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
- •The subject must weigh at least 45 kg and have a body mass index (BMI) between 20.0 and 32.0 kg/m2
- •The subject must have a normal or clinically nonsignificant 12 lead ECG as well as normal or clinically non-significant laboratory test results
- •Female subjects must be post-menopausal (defined as at least 2 years without menses) surgically sterile, or practicing effective contraception, and will continue to use effective contraception during the study period. All females must be non-lactating, and should have a negative pregnancy test result
- •The subject must have negative test results for drugs of abuse and alcohol screens
- •The subject must have a good venous access in both arms
排除标准
- •The subject has evidence of QTc interval >430 msec for male, >450 msec for female
- •The subject has liver function test values (ALT, AST, or bilirubin) above the upper limit of normal
- •The subject has a history or presence of psychiatric illness, serious active or recurrent infection
- •The subject has a previous history of cancer other than basal cell carcinoma or Stage 1 squamous cell carcinoma that has not been in remission for at least 5 years
- •The subject has donated or lost ≥ 450 mL blood within 56 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration
- •The subject has received or is anticipated to receive a prescription drug within 14 days (within 30 days for any long acting treatments such as depot formulations). Subject has taken any over-the-counter (OTC) medications, including complementary and alternative medicines (except for oral contraceptives and occasional use of acetaminophen of up to 2000 mg/day but not more than 4 days per week) within 14 days
- •The subject has consumed alcohol, xanthine derivative-containing beverages/food (tea/chocolate), grapefruit juice, grapefruit-containing products or Seville oranges (e.g., bitter marmalade) within 48 hours before admission into the unit
- •The subject has used tobacco-containing products and nicotine-containing products within 6 months
- •The subject consumes more than 5 units of alcoholic beverages (one unit is 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) per week, or has a history of substance abuse, drug addiction, or alcoholism within past 2 years
- •The subject is known to have hepatitis or HIV-1 and/or HIV-2, or is positive for hepatitis A antibody IgM, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody
研究组 & 干预措施
1. mirabegron, low dose
Oral mirabegron 25 mg
干预措施: mirabegron (Drug)
2. mirabegron, middle dose
Oral mirabegron 50 mg
干预措施: mirabegron (Drug)
3. mirabegron, higher dose
Oral mirabegron 100 mg
干预措施: mirabegron (Drug)
结局指标
主要结局
Characterize the pharmacokinetic profile of 3 doses of oral mirabegron formulations with three different release rates vs. three doses of mirabegron administered intravenously
时间窗: 2 months
次要结局
- Assess the safety and tolerability of intravenously administered mirabegron(2 months)
- Assess the safety and tolerability of three doses of orally administered mirabegron formulated with three different release rates(2 months)