NCT07641881已完成1 期
A Phase 1, Open-Label, Randomized, Single-Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Pharmacokinetic Study to Evaluate the Bioequivalence of Two Casdatifan (AB521) Tablet Strengths and Food Effect in Healthy Adult Participants
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to compare the single-dose pharmacokinetics (PK) of casdatifan 100 mg versus four 25 mg tablets under fasting conditions in healthy adult participants, and to evaluate the effect of food on the single-dose PK of casdatifan 100 mg administered as four 25 mg tablets in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting.
- •BMI ≥ 18.0 and ≤ 32.0 kg/m2 and body weight ≥ 45 kg at the screening visit.
- •Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, standard vital signs, and ECGs, as deemed by the PI or designee.
- •Able to swallow multiple tablets.
- •Has adequate peripheral venous access.
排除标准
- •Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- •History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- •History of asthma or chronic obstructive pulmonary disease (including childhood), clinically significant food allergies or anaphylaxis, as deemed by PI or designee.
- •Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones).
- •Seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions which the PI or designee considers to be clinically significant.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Treatment B
Experimental
Participants will receive 1 X 100 mg tablets of casdatifan.
干预措施: Casdatifan (Drug)
Treatment A
Experimental
Participants will receive 4 X 25 mg tablets of casdatifan.
干预措施: Casdatifan (Drug)
Treatment C
Experimental
Participants will receive 4 X 25 mg tablets of casdatifan under fed conditions.
干预措施: Casdatifan (Drug)
研究者
研究点 (2)
Loading locations...
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