A Phase 1, Open-label Study to Assess the Mass Balance, Metabolism, Excretion and Pharmacokinetics of a Single Subcutaneous Dose of [14C]-ITI-1284 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Mass balance recovery of total radioactivity in urine and feces combined
研究概览
简要总结
ITI-1284-012 is an open-label, single-dose study to assess the mass balance recovery of radioactivity, and to evaluate the pharmacokinetics, safety and tolerability of ITI-1284 after a single subcutaneous dose of [14C]-ITI-1284 in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between 30 and 55 years of age (inclusive);
- •BMI between18.0 and 32.0 kg/m2, inclusive, at screening, and a minimum body weight of 50 kg at screening;
- •Willing to be confined to the clinical research unit for the duration of the inpatient period of the study.
排除标准
- •Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposure, exceeding 5 mSev in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker shall participate in the study;
- •Subjects who have been enrolled in a 14C-labeled product study in the 10 months prior to dosing with study drug on Day 1;
- •Any clinical condition or procedure that may affect the absorption, distribution, biotransformation, or excretion of ITI-
- •Subjects with a history of appendectomy and/or abdominal wall hernia repair are eligible for study participation provided surgery was performed ≥1 year ago;
- •Acute diarrhea or constipation in the 7 days before Day
- •If screening occurs > 7 days before Day 1, this criterion will be determined on Day 1;
- •Clinically significant abnormal findings in vital sign assessments, supine SBP > 140 mmHg or < 90 mmHg, or supine DBP >90 mmHg or < 50 mmHg or supine pulse rate > 100 bpm or < 45 bpm at Screening;
- •History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study.
研究组 & 干预措施
[14C]-ITI-1284 20 mg
干预措施: [14C]-ITI-1284 (Drug)
结局指标
主要结局
Mass balance recovery of total radioactivity in urine and feces combined
时间窗: Day 1 up to Day 29
percentage of total radioactivity
Pharmacokinetics: AUC0-t for total radioactivity
时间窗: Day 1 up to Day 29
Area under the plasma drug concentration-time curve (AUC) from time zero to the last measurable concentration
Pharmacokinetics: AUC0-t for ITI-1284
时间窗: Day 1 to Day 8
Area under the plasma drug concentration-time curve (AUC) from time zero to the last measurable concentration
Pharmacokinetics: Cmax for total radioactivity
时间窗: Day 1 up to Day 29
Maximum plasma concentration
Pharmacokinetics: Cmax for ITI-1284
时间窗: Day 1 to Day 8
Maximum plasma concentration
Pharmacokinetics: Tmax for total radioactivity
时间窗: Day 1 up to Day 29
Time of maximum plasma concentration
Pharmacokinetics: Tmax for ITI-1284
时间窗: Day 1 to Day 8
Time of maximum plasma concentration
次要结局
- Percentage of subjects with treatment-emergent adverse events(Up to 30 days after the dose of study drug)
- Change from baseline in systolic and diastolic blood pressure(Day 14)
- Change from baseline in ECG QT interval(Day 14)