An Open-label, Phase I Study to Evaluate the Relative Bioavailability, Food Effect and Pharmacokinetic Linearity of 2 New Tablet Formulations (Adult and Pediatric) of Selitrectinib (BAY 2731954) in Relative to Oral Suspension and the Liquid Service Formulation in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- AUC
研究概览
简要总结
In this study, the researchers will compare 2 new tablet forms of BAY2731954 with liquid oral forms of BAY2731954. A maximum of 61 healthy volunteers aged 18 to 55 will be asked to participate.
The study will have 2 parts. In part 1 researchers want to gather information how the body absorbs, distributes and excretes the drug BAY2731954 given as two different tablet formulations. Participants will take the study drugs on 3 days separated by breaks of at least 3 days between each intake. The duration of this study part will be in total of up to 6 weeks from first screening visit to follow-up visit.
In part 2 of the study researchers want to study how the body absorbs, distributes and excretes the drug BAY2731954 given as two different tablet formulations with or without food or as 2 liquid oral formulations. Participants will take the study drugs on 4 days separated by breaks of at least 3 days between each intake. The duration of the second part of study part will be in total of up to 7 weeks from first screening visit to follow-up visit.
During the study, researchers will collect blood and urine samples. In addition, doctors will check the participants' overall health. They will also ask the participants if they have any medical problems.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are overtly healthy as determined by the investigator or medically qualified designee based on medical evaluation including medical history, laboratory tests, physical, cardiac and neurologic examination
- •Body mass index (BMI): ≥18.5 and ≤ 29.9 kg/m2, with body weight ≥50 kg
- •Use of adequate contraception until 3 months after last study intervention
排除标准
- •Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (e.g. seizures) or other organs (e.g. diabetes mellitus).
- •Medical history of risk factors for Torsades de pointes (e.g. family history of Long QT Syndrome) or other arrhythmias
- •Known severe allergies, allergies requiring therapy with corticosteroids, non-allergic drug reactions, or (multiple) drug allergies (excluding untreated asymptomatic seasonal allergies such as non-severe hay fever during the time of study conduct).
- •Regular use of medicines
- •Regular alcohol consumption
- •Smoking more than 5 cigarettes daily
- •History of COVID-19 or current SARS-CoV-2 infection
研究组 & 干预措施
Part 1: Group B
Participants will receive 3 single doses of selitrectinib in pediatric tablet formulation sequentially in 3 treatment periods. The washing-out period between each dose is at least 3 days
干预措施: Selitrectinib (BAY2731954) Pediatric tablet (Drug)
Part 2 (Group B): Dose D-C-B-A
Participants will receive dose D, C, B and A sequentially. The washing-out period between each dose is at least 3 days
干预措施: Selitrectinib (BAY2731954) Pediatric tablet (Drug)
Part 2 (Group B): Dose C-A-D-B
Participants will receive dose C, A, B and D sequentially. The washing-out period between each dose is at least 3 days
干预措施: Selitrectinib (BAY2731954) Pediatric tablet (Drug)
Part 2 (Group B): Dose D-C-B-A
Participants will receive dose D, C, B and A sequentially. The washing-out period between each dose is at least 3 days
干预措施: Selitrectinib (BAY2731954) Oral suspension (Drug)
Part 2 (Group B): Dose C-A-D-B
Participants will receive dose C, A, B and D sequentially. The washing-out period between each dose is at least 3 days
干预措施: Selitrectinib (BAY2731954) Oral suspension (Drug)
Part 2 (Group B): Dose B-D-A-C
Participants will receive dose B, D, A and C sequentially. The washing-out period between each dose is at least 3 days
干预措施: Selitrectinib (BAY2731954) Oral suspension (Drug)
Part 2 (Group B): Dose B-D-A-C
Participants will receive dose B, D, A and C sequentially. The washing-out period between each dose is at least 3 days
干预措施: Selitrectinib (BAY2731954) Pediatric tablet (Drug)
Part 2 (Group B): Dose A-B-C-D
Participants will receive dose A, B, C and D sequentially. The washing-out period between each dose is at least 3 days
干预措施: Selitrectinib (BAY2731954) Oral suspension (Drug)
Part 2 (Group B): Dose A-B-C-D
Participants will receive dose A, B, C and D sequentially. The washing-out period between each dose is at least 3 days
干预措施: Selitrectinib (BAY2731954) Pediatric tablet (Drug)
Part 2 (Group A): Dose C-A-B-D
Participants will receive dose C, A, B and D sequentially. The washing-out period between each dose is at least 3 days
干预措施: Selitrectinib (BAY2731954) Oral suspension (Drug)
Part 2 (Group A): Dose C-A-B-D
Participants will receive dose C, A, B and D sequentially. The washing-out period between each dose is at least 3 days
干预措施: Selitrectinib (BAY2731954) Oral solution (Drug)
Part 2 (Group A): Dose C-A-B-D
Participants will receive dose C, A, B and D sequentially. The washing-out period between each dose is at least 3 days
干预措施: Selitrectinib (BAY2731954) Adult tablet (Drug)
Part 2 (Group A): Dose B-C-A-D
Participants will receive dose B, C, A and D sequentially. The washing-out period between each dose is at least 3 days
干预措施: Selitrectinib (BAY2731954) Oral suspension (Drug)
Part 2 (Group A): Dose B-C-A-D
Participants will receive dose B, C, A and D sequentially. The washing-out period between each dose is at least 3 days
干预措施: Selitrectinib (BAY2731954) Oral solution (Drug)
Part 2 (Group A): Dose B-C-A-D
Participants will receive dose B, C, A and D sequentially. The washing-out period between each dose is at least 3 days
干预措施: Selitrectinib (BAY2731954) Adult tablet (Drug)
Part 2 (Group A): Dose A-B-C-D
Participants will receive dose A, B, C and D sequentially. The washing-out period between each dose is at least 3 days
干预措施: Selitrectinib (BAY2731954) Oral suspension (Drug)
Part 2 (Group A): Dose A-B-C-D
Participants will receive dose A, B, C and D sequentially. The washing-out period between each dose is at least 3 days
干预措施: Selitrectinib (BAY2731954) Oral solution (Drug)
Part 2 (Group A): Dose A-B-C-D
Participants will receive dose A, B, C and D sequentially. The washing-out period between each dose is at least 3 days
干预措施: Selitrectinib (BAY2731954) Adult tablet (Drug)
Part 1: Group A
Participants will receive 3 single doses of selitrectinib in adult tablet formulation sequentially in 3 treatment periods. The washing-out period between each dose is at least 3 days
干预措施: Selitrectinib (BAY2731954) Adult tablet (Drug)
结局指标
主要结局
AUC
时间窗: Up to 48 hours after dosing
Area under the plasma concentration vs. time curve from 0 to infinity after single dose To evaluate the pharmacokinetic linearity of selitrectinib after a single dose of adult tablet and pediatric tablet and to evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral suspension formulation and the food effect on the bioavailability of 2 new tablet formulations
AUC(0-24)
时间窗: Up to 24 hours after dosing
Area under the plasma concentration vs. time curve from 0 to 24 hours after single dose To evaluate the pharmacokinetic linearity of selitrectinib after a single dose of adult tablet and pediatric tablet and to evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral suspension formulation and the food effect on the bioavailability of 2 new tablet formulations
Cmax
时间窗: Up to 48 hours after dosing
Maximum observed drug concentration in measured matrix after single dose administration To evaluate the pharmacokinetic linearity of selitrectinib after a single dose of adult tablet and pediatric tablet and to evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral suspension formulation and the food effect on the bioavailability of 2 new tablet formulations
次要结局
- ECG QRS duration(Up to 7 weeks)
- ECG PR interval(Up to 7 weeks)
- ECG QT interval(Up to 7 weeks)
- AUC(Up to 48 hours after dosing)
- AUC(0-24)(Up to 24 hours after dosing)
- Cmax(Up to 48 hours after dosing)
- Number of participants with treatment emergent adverse events and severity of treatment emergent adverse events(Up to 7 weeks)
- Incidence of laboratory abnormalities, based on clinical safety laboratory assessments(Up to 7 weeks)
- Ventricular rate(Up to 7 weeks)
- Blood pressure in mmHg(Up to 7 weeks)
- Heart rate in bpm(Up to 7 weeks)
- Body temperature in Celsius(Up to 7 weeks)
- Respiratory rate in breaths/min(Up to 7 weeks)