NL-OMON51471
已完成
不适用
A randomized, double-blind, placebo-controlled study of the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of CFTX-1554 in healthy subjects, with comparison of intake of CFTX-1554 as liquid formulation and as capsule, and after a high-fat breakfast versus fasted. - SAD / MAD/ FE HV
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- nerve pain (peripheral neuropathic pain)
- 发起方
- Confo Therapeutics
- 入组人数
- 107
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Sex: male or female.
- •2\. Age: Part A and B \- 18 to 55 years, inclusive, at screening. Part C \- 18 to
- •35 years, inclusive, at screening
- •3\. Body mass index (BMI): 18\.0 to 30\.0 kg/m2, inclusive, at screening.
- •4\. At screening, females may be of childbearing potential but not pregnant or
- •lactating, or they may be of nonchildbearing potential (either surgically
- •sterilized or physiologically incapable of becoming pregnant, or at least 1
- •year postmenopausal \[amenorrhea duration of 12 consecutive months]);
- •nonpregnancy will be confirmed for all females by a serum pregnancy test
- •conducted at screening, (each) admission, and at follow\-up.
排除标准
- •1\. Previous participation in the current study.
- •2\. History of relevant drug and/or food allergies.
- •3\. Allergy or hypersensitivity to active ingredient or excipients..
- •4\. Using nicotine\-containing products within 60 days prior to (the first) drug
- •administration.
- •5\. History of alcohol abuse or drug addiction (including soft drugs like
- •cannabis products) within 1 year prior to screening.
- •Further criteria apply
结局指标
主要结局
未指定
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