NCT05004311已完成1 期
An Open-label, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cenerimod After Single-dose Administration in Subjects With Severe Renal Impairment and Control 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
- 16
- 试验地点
- 1
- 主要终点
- The time to reach Cmax (tmax) of cenerimod
研究概览
简要总结
To investigate the PK of cenerimod in participants with severe renal impairment as compared to healthy control participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
- •Women of childbearing potential must have a negative serum pregnancy test at screening, a negative urine pregnancy test on Day -1, and agree to consistently and correctly use a highly effective method of contraception.
- •Women of non-childbearing potential.
- •Body mass index of 18.0 to 35.0 kg/m2 (inclusive) at Screening
- •Negative SARS-CoV-2 reverse transcription polymerase chain reaction test on Day -
- •Additional inclusion criteria for participants with severe renal impairment
- •Estimated glomerular filtration rate (eGFR) at screening using the Modification of Diet in Renal Disease formula less-than 30 mL/min/1.73 m2 for participants with renal impairment. The eGFR value should be confirmed on Day -
- •Systolic blood pressure (SBP) 100 to 180 mmHg, diastolic BP (DBP) 50 to 105 mmHg, and pulse rate 60 to 100 bpm (inclusive), on Day 1 pre-dose.
- •Stable concomitant medications for at least 3 weeks prior to screening and up to Day
- •Aspartate aminotransferase and alanine aminotransferase above the upper limit of normal.
- •Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry, and urinanalysis) except for those related to renal impairment at Screening and on Day-
- •Additional inclusion criteria for control participants
- •eGFR at Screening using the Modification of Diet in Renal Disease formula of ≥ 90 mL/min/1.73 m
- •SBP 90 to 139 mmHg, DBP 60 to 89 mmHg, and pulse rate 60 to 99 bpm, measured on the same arm, after 5 min in the supine position at screening and on Day 1 pre-dose.
排除标准
- •Pregnant or lactating women.
- •Participation in a clinical study involving study treatment administration within 3 months prior to screening or participation in more than 2 clinical studies within 1 year prior to Screening.
- •Previous exposure to cenerimod.
- •Known hypersensitivity to any excipients of the treatment formulation.
- •Clinically relevant abnormalities on a 12-lead electrocardiogram at Screening and Day -
- •Previous treatment with anti-arrhythmic medications of class Ia or III within 2 weeks or 5 half-lives, whichever is longer, prior to study treatment administration.
- •History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatment except for renal disease, appendectomy, herniotomy, or cholecystectomy.
- •Aspartate aminotransferase and alanine aminotransferase above the upper limit of normal.
- •Legal incapacity or limited legal capacity at Screening.
- •Additional exclusion criteria for participants with severe renal impairment:
- •Presence of severe cardiac disease.
- •End-stage renal disease that requires dialysis.
- •History of severe renal artery stenosis.
- •Serum potassium concentration > 5.5 mmol/L.
- •Presence of unstable diabetes mellitus.
- •Strict fluid restriction.
- •Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry, and urinalysis) except for those related to renal impairment at Screening and on Day -
- •Additional exclusion criteria for control participants
- •Clinically relevant findings on the physical examination at Screening.
- •Clinically relevant findings in clinical laboratory tests.
研究组 & 干预措施
Group A (severe renal function impairment)
Experimental
Eight (8) participants with severe renal impairment.
干预措施: Cenerimod (Drug)
Group B (healthy)
Experimental
Eight (8) control participants, matched to the 8 severe renal impaired participants enrolled in Group A.
干预措施: Cenerimod (Drug)
结局指标
主要结局
The time to reach Cmax (tmax) of cenerimod
时间窗: Total duration: up to 52 days
Extent of cenerimod protein plasma binding (PPB)
时间窗: Total duration: up to 52 days
The maximum plasma concentration (Cmax) of cenerimod
时间窗: Total duration: up to 52 days
Area under the plasma concentration-time curve (AUC from 0 to infinity) of cenerimod
时间窗: Total duration: up to 52 days
Apparent volume of distribution (Vz/F) of cenerimod
时间窗: Total duration: up to 52 days
Area under the plasma concentration-time curve (AUC) from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t) of cenerimod
时间窗: Total duration: up to 52 days
Terminal half-life (t½) of cenerimod
时间窗: Total duration: up to 52 days
Apparent oral clearance (CL/F) of cenerimod
时间窗: Total duration: up to 52 days
次要结局
- Change from baseline at each time point of measurement in electrocardiogram QT interval(Total duration: up to 66 days)
- Change from baseline in body weight(Total duration: up to 66 days)
- Incidence of abnormal laboratory test results(Total duration: up to 66 days)
- Change from baseline in systolic and diastolic blood pressure (in the supine position)(Total duration: up to 66 days)
- Total lymphocyte count count.(Total duration: up to 66 days)
研究者
研究点 (1)
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