An Open-Label, Phase 1 Study to Investigate the Absolute Bioavailability and the Absorption, Metabolism, and Excretion of [14C]-Mosliciguat in Healthy, Adult Males
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Determine the absolute bioavailability (ABA) of mosliciguat following administration of a single inhaled dose of mosliciguat followed by an IV microtracer dose of [14C]-mosliciguat in healthy adult males
研究概览
简要总结
This is a single-center, Phase 1, open-label, 3-period, fixed-sequence study to investigate the bioavailability, absorption, metabolism, excretion and the safety of mosliciguat administered to healthy male adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participants willing and able to provide informed consent.
- •Considered to be in good health by the Investigator, as determined by medical history, physical examination, vital sign measurements, 12 lead electrocardiogram (ECG), and laboratory test results.
排除标准
- •History or presence of any condition (e.g., chronic diarrhea, urinary incontinence), or prior surgery (e.g., gastric bypass) that, in the opinion of the Investigator, poses a significant risk to participant safety and/or achievement of study objectives
- •History or presence of COPD, moderate or persistent asthma, other chronic lung disease, or chronic respiratory condition within the last 5 years
- •Acute or recent respiratory infection symptoms not resolved at least 3 days prior to Period 1 check-in.
研究组 & 干预措施
Mosliciguat (RVT-2301)
Mosliciguat administered daily via dry powder inhaler.
干预措施: Mosliciguat (Drug)
Mosliciguat (RVT-2301)
Mosliciguat administered daily via dry powder inhaler.
干预措施: Dry Powder Inhaler (Device)
14C mosliciguat
Administered orally and via IV
干预措施: 14C mosliciguat (Drug)
结局指标
主要结局
Determine the absolute bioavailability (ABA) of mosliciguat following administration of a single inhaled dose of mosliciguat followed by an IV microtracer dose of [14C]-mosliciguat in healthy adult males
时间窗: Baseline, Day 7
Absolute bioavailability of inhaled mosliciguat
Area under the concentration-time curve (AUC) for mosliciguat
时间窗: Baseline, Day 7
Assess the mass balance (i.e., cumulative excretion in urine and feces compared to the administered amount of radioactive isotope) of [14C] following a single oral dose of mosliciguat solution
时间窗: Baseline, Day 28
Urine and fecal recovery of total \[14C\] radioactivity, \[14C\]-mosliciguat
Maximum observed concentration (Cmax)
时间窗: Baseline, Day 7
次要结局
- Evaluate the incidence of Treatment-Emergent Adverse Events (safety and tolerability of mosliciguat)(Baseline, Day 44)