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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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.
- •5. Female subjects of childbearing potential who have a fertile male sexual
- •partner must agree to use adequate contraception from at least 4 weeks prior to
- •(first) administration of the study drug until 90 days after the follow up
- •visit. Adequate contraception is defined as using hormonal contraceptives or an
- •intrauterine device combined with at least 1 of the following forms of
- •contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from
- •heterosexual intercourse, in accordance with the lifestyle of the subject, is
- •also acceptable.
- •Further criteria apply
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
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