NCT06801418已完成1 期
A Phase 1, Open-label, Randomized, 2-sequence, 4-period, Fully-replicate, Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets in Healthy Adult Participants
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
- 160
- 试验地点
- 3
- 主要终点
- Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]
研究概览
简要总结
This is a study to evaluate bioequivalence between adagrasib reference tablets and high drug load 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult participants without clinically significant deviation from normal in medical history physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory assessments as determined by the investigator.
- •Body mass index of 18.0 kg/m2 to 32.0 kg/m^2, inclusive, (BMI may be rounded, eg, a participant with a BMI of 32.4 kg/m^2 would qualify; a participant with a BMI of 32.5 kg/m^2 or higher would not qualify). BMI = weight (kg)/(height [m])^
- •Total body weight ≥ 50 kg.
- •Individuals of childbearing potential (IOCBP) and male (as assigned at birth) participants who are sexually active with IOCBP must agree to follow instructions for method(s) of contraception as included in the ICF.
- •A female (as assigned at birth) is eligible to participate if she is not pregnant or breastfeeding and at least 1 of the following conditions applies:
- •Is not an IOCBP, OR
- •Is an IOCBP and using a non-hormonal contraceptive method that is highly effective (with a failure rate of < 1% per year).
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator.
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, any components of the IMP, or other substance (not including seasonal allergies), unless approved by the investigator and medical monitor.
- •History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions.
- •History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study, including any of the following:
- •i. History of myocardial infarction ii. Heart failure iii. Unstable angina (within 6 months of Day -1) iv. High-risk or symptomatic cardiac arrhythmias (eg, sustained ventricular tachycardia, second- or third-degree atrioventricular block without a pacemaker) v. Hypertension.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Adagrasib sequence A
Experimental
干预措施: Adagrasib (Drug)
Adagrasib sequence B
Experimental
干预措施: Adagrasib (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]
时间窗: Up to Day 28
Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]
时间窗: Up to Day 28
Maximum Observed Plasma Concentration (Cmax)
时间窗: Up to Day 28
次要结局
- Number of Participants with Vital Sign Abnormalities(Up to Day 28)
- Number of Participants with Treatment Emergent Adverse Events (AEs)(Up to Day 34)
- Number of Participants with Clinical Laboratory Test Abnormalities(Up to Day 28)
- Number of Participants with Physical Examination Abnormalities(On Day 28)
- Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities(Up to Day 28)
- Time of Maximum Observed Plasma Concentration (Tmax)(Up to Day 28)
- Apparent Terminal Phase Half-life (T-HALF)(Up to Day 28)
研究者
研究点 (3)
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