NCT05924152已完成1 期
A Phase 1, Open-label, One-sequence Crossover Study to Investigate the Effect of a Breast Cancer Resistance Protein Inhibitor on the Single-dose Pharmacokinetics of Adagrasib in Healthy Adult 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
- Pharmacokinetics - Cmax (adagrasib)
研究概览
简要总结
A Phase 1, Open-label, One-sequence Crossover Study to Investigate the Effect of a Breast Cancer Resistance Protein Inhibitor on the Single-dose Pharmacokinetics of Adagrasib in Healthy Adult Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Males or females, of any race, between 18 and 60 years of age, inclusive, at Screening.
- •Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
- •In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, or clinical laboratory evaluations at Screening and Check-in as assessed by the Investigator.
- •Females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy test at Screening and Check-in. Females of childbearing potential must agree to use contraception.
- •Male subjects must agree to use contraception.
- •Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, thrombotic, 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 investigational product (IP), or other substance (not including seasonal allergies).
- •History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome).
- •Significant history or clinical manifestation of any hepatic disease, as determined by laboratory abnormalities.
- •History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study.
- •Ventricular dysfunction or history of risk factors for Torsades de Pointes.
- •History of drug abuse within 2 years prior to Screening.
- •History of alcohol abuse within 12 months prior to Screening.
- •Positive serology test results for hepatitis B surface antigen, hepatitis C antibody, and/or human immunodeficiency virus (HIV) 1/
- •Use of tobacco- or nicotine-containing products within 3 months prior to Check-in.
- •Use of any drugs or substances known or suspected to alter drug absorption, distribution, metabolism, or elimination.
- •Use or intend to use any prescription medications/products within 14 days prior to Check-in.
- •Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations.
- •Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days.
- •Subjects who, in the opinion of the Investigator, should not participate in this study.
研究组 & 干预措施
Treatment A
Active Comparator
Treatment A: A single oral dose of adagrasib 400 mg (2 × 200-mg tablets) on Day 1;
干预措施: Adagrasib (Drug)
Treatment B
Active Comparator
Treatment B: A single oral dose of eltrombopag 75 mg
(1 × 75-mg tablet) plus adagrasib 400 mg (2 × 200-mg tablets) on Day 8.
干预措施: Eltrombopag + adagrasib (Drug)
结局指标
主要结局
Pharmacokinetics - Cmax (adagrasib)
时间窗: Days 1 and 8
Maximum observed plasma concentration (Cmax)
Pharmacokinetics - AUC (adagrasib)
时间窗: Days 1 and 8
AUC from time zero to the last quantifiable concentration (AUClast)
Pharmacokinetics - t1/2 (adagrasib)
时间窗: Days 1 and 8
Elimination half-life (t1/2)
Pharmacokinetics - Tmax (adagrasib)
时间窗: Days 1 and 8
Time to reach Cmax (tmax)
Pharmacokinetics - CL/F (adagrasib)
时间窗: Days 1 and 8
Apparent total plasma clearance (CL/F)
Pharmacokinetics - Vz/F (adagrasib)
时间窗: Days 1 and 8
Apparent volume of distribution (Vz/F)
次要结局
- Adverse Events (AEs)(Up to 8 weeks from screening)
研究者
研究点 (1)
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