NCT02938507已完成1 期
A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Immediate and Modified Release Formulations of Orally Administered Solabegron in Healthy Male Subjects
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
- 24
- 主要终点
- Maximum observed plasma drug concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of different formulations of orally administered solabegron in healthy male subjects.
详细描述
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of different formulations of orally administered solabegron in healthy male subjects. Eligible male subjects will be enrolled into 2 cohorts of 12 subjects each conducted in parallel. The study is a single blind (subjects), randomized, cross-over design in 3 study periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body weight greater than or equal to 50 kg, inclusive, and body mass index (BMI) 18.0 - 32.0 kg/m2, inclusive
- •In good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation. Results of clinical laboratory tests must be without clinically significant abnormalities, including hematology, clinical chemistry and urinalysis.
- •Adequate venous access to allow for repeated blood sampling
- •Ability to understand and comply with the study requirements
- •Provide written informed consent prior to any study procedure being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read).
排除标准
- •Any clinically relevant abnormality identified on the screening physical examination, clinical laboratory tests, 12-lead ECG, or any other medical condition or circumstance which would make the subject unsuitable for participation in the study based on the Investigator's assessment
- •Resting heart rate greater than or equal to 100 beats per minute (BPM) after 5 minutes rest (as above) at the screening visit
- •QTcF interval (Fredericia's correction factor) greater than 450 msec (males subjects) at screening
- •History of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation
- •History of smoking, including e-cigarettes, within 3 months of the study and/or a positive urine cotinine at screening
- •Regular alcohol consumption averaging ≥ 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of the first dose of study medication.
- •Positive urine drug or alcohol test at screening
- •Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (e.g., due to expected study medication non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)
研究组 & 干预措施
Formulation 1 solabegron
Experimental
Subjects will receive formulation 1 solabegron doses in a single-blind, randomized, cross-over fashion in Periods 1 to 3.
干预措施: Formulation 1 solabegron (Drug)
Formulation 2 solabegron
Experimental
Subjects will receive formulation 2 in a single-blind, randomized, cross-over fashion in Periods 1 to 3.
干预措施: Formulation 2 solabegron (Drug)
结局指标
主要结局
Maximum observed plasma drug concentration (Cmax)
时间窗: 24 hours
次要结局
未报告次要终点
研究者
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