A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Different Multiple Dose Regimens of RDX5791 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Ardelyx
- 入组人数
- 105
- 主要终点
- Safety of different dosing regimens of RDX5791
研究概览
简要总结
A Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerabiltiy, and pharmacodynamics of different multiple dose regimens of RDX5791 in healthy volunteers.
详细描述
The starting doses for this study are based on the results from the multiple ascending-dose study performed on RDX5791 (Protocol RDX5791-101). Subjects will be screened within 3 weeks of check in to the CPU. Each cohort of 15 subjects (12 RDX5791, 3 placebo) will check in to the CPU on Day -5 before dinner. Each subject will receive a diet standardized for Na+ content while in the CPU. Subjects will receive doses of RDX5791 with approximately 240 mL of non-carbonated water on Days 1 to 7 (just prior to meals, depending on QD, bid, or tid regimens). Subjects will be provided standardized meals within 10 minutes after dosing. Doses can be administered with breakfast, lunch, or dinner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 18 and 29.9 kg/m², inclusive
- •No clinically significant abnormalities in medical history
- •Females must be non-pregnant, non-lactating, and either postmenopausal for at least 12 months or have agreed to use an effective form of contraception from the time of signing the informed consent until 45 days after end of study
- •Men must be either sterile, abstinent, or agreed to use an approved method of contraception from check-in until 45 days after final study visit
排除标准
- •Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract
- •Any surgery on the small intestine or colon, excluding appendectomy
- •Loose stools (Bristol Stool Form Score of 6 or 7) ≥2 days in the past 7 days
- •Hepatic dysfunction ([ALT] or [AST]) >1.5 times the upper limit of normal or renal impairment
- •Any evidence of or treatment of malignancy, excluding non-melanomatous malignancies of the skin
- •Use of diuretic medications, medications that are known to affect stool consistency and/or GI motility
- •Use of an investigational agent within 30 days prior to Day -2
- •Positive virology, alcohol, or drugs of abuse test during screening
- •Use of any prescription medication within 7 days before admission to the CPU
- •Have had significant blood loss (>450 mL) or have donated 1 or more units of blood or plasma within 8 weeks prior to study entry
研究组 & 干预措施
30 mg bid
30 mg of RDX5791 administered twice daily PO (60 mg total dose/day).
干预措施: RDX5791 (Drug)
30 mg bid
30 mg of RDX5791 administered twice daily PO (60 mg total dose/day).
干预措施: Placebo (Drug)
30 mg tid
30 mg of RDX5791 administered three times daily PO (90 mg total dose/day).
干预措施: RDX5791 (Drug)
30 mg tid
30 mg of RDX5791 administered three times daily PO (90 mg total dose/day).
干预措施: Placebo (Drug)
60 mg bid
60 mg of RDX5791 administered two times daily (120 mg total dose/day).
干预措施: RDX5791 (Drug)
60 mg bid
60 mg of RDX5791 administered two times daily (120 mg total dose/day).
干预措施: Placebo (Drug)
15 mg bid
15 mg of RDX5791 administered two times daily (30 mg total dose/day).
干预措施: RDX5791 (Drug)
15 mg bid
15 mg of RDX5791 administered two times daily (30 mg total dose/day).
干预措施: Placebo (Drug)
30 mg QD
30 mg of RDX5791 administered once daily (30 mg total dose/day).
干预措施: RDX5791 (Drug)
30 mg QD
30 mg of RDX5791 administered once daily (30 mg total dose/day).
干预措施: Placebo (Drug)
Escalating dose bid
15 mg or 30 mg or 45 mg of RDX5791 administered two times daily (30, 60, or 90 mg total dose/day respectively). The stopping criteria for the dose escalation is based on Bristol Stool Score and AEs.
干预措施: RDX5791 (Drug)
Escalating dose bid
15 mg or 30 mg or 45 mg of RDX5791 administered two times daily (30, 60, or 90 mg total dose/day respectively). The stopping criteria for the dose escalation is based on Bristol Stool Score and AEs.
干预措施: Placebo (Drug)
30 mg bid with psyllium
30 mg of RDX5791 administered two times daily (60 mg total dose/day) with psyllium taken up to three times per day (maximum of 15 g psyllium/day).
干预措施: RDX5791 (Drug)
30 mg bid with psyllium
30 mg of RDX5791 administered two times daily (60 mg total dose/day) with psyllium taken up to three times per day (maximum of 15 g psyllium/day).
干预措施: Placebo (Drug)
结局指标
主要结局
Safety of different dosing regimens of RDX5791
时间窗: 7 Days
Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams.
次要结局
- Pharmacodynamics of different dosing regimens of RDX5791(7 Days)