NCT05868356已完成1 期
A Phase 1, Open-label, Multiple-dose, One-sequence Crossover Study to Investigate the Effect of Repeated Oral Doses of a Strong CYP2C8 Inhibitor on the Steady-state Pharmacokinetics of Adagrasib in Healthy Adult Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Pharmacokinetics - AUC (adagrasib)
研究概览
简要总结
A Phase 1, Open-label, Multiple-dose, One-sequence Crossover Study to Investigate the Effect of Repeated Oral Doses of a Strong CYP2C8 Inhibitor on the Steady-state 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, 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) likely to alter absorption of study treatment or result in inability to swallow oral medications.
- •Significant history or clinical manifestation of any hepatic disease.
- •History or current diagnosis of uncontrolled or significant cardiac disease.
- •Ventricular dysfunction or history of risk factors for Torsades de Pointes.
- •History of allergic reaction to fibric acid derivatives.
- •History of drug abuse within 2 years prior to Screening.
- •History of alcohol abuse within 12 months prior to Screening.
- •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.
- •Use or intend to use slow-release medications/products considered to still be active within 14 days prior to Check-in.
- •Participation in a clinical study involving administration of an investigational drug in the past 30 days or 5 half-lives prior to dosing, whichever is longer.
- •Have previously completed or withdrawn from this study or any other study investigating adagrasib, and have previously received the IP.
- •Receipt of blood products within 3 months prior to Check-in.
- •Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
- •Subjects who, in the opinion of the Investigator, should not participate in this study.
结局指标
主要结局
Pharmacokinetics - AUC (adagrasib)
时间窗: Days 1, 8, and 18
Area under the plasma concentration time curve (AUC) during a dosage interval (AUCtau)
Pharmacokinetics - Cmax (adagrasib)
时间窗: Days 1, 8, and 18
Maximum observed plasma concentration
Pharmacokinetics - Tmax (adagrasib)
时间窗: Days 1, 8, and 18
Time to reach Cmax (tmax)
次要结局
- Adverse Events (AEs)(Up to 9 weeks from screening)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Study to Assess Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in Healthy ParticipantsHealthyNCT04090086Janssen Research & Development, LLC16
已完成
1 期
Study to Evaluate the Effect of Multiple-Dose Ritlecitinib on the Pharmacokinetics (PK) of TolbutamideHealthy VolunteersNCT05097716Pfizer12
已完成
1 期
A Study on The Effect of Multiple Doses of Activated Charcoal on The Pharmacokinetics of a Single Dose of RO4995819Healthy VolunteerNCT01409369Hoffmann-La Roche26
已完成
1 期
Drug-drug Interaction Study Between EDP-305, Midazolam, Caffeine and Rosuvastatin in Healthy Volunteers.NASHNCT03187496Enanta Pharmaceuticals, Inc24
已完成
1 期
The Effect of Itraconazole on BCT197 Exposure in Healthy Male ParticipantsInteractionNCT03498170Mereo BioPharma16