Phase I, Open-Label, Randomized, Single-Dose Study With Crossover Design to Investigate the Effect of Food on the PK of Peposertib Tablet Formulation and to Investigate the PK of Peposertib Administered as Oral Suspension of Disintegrated Tablets
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Part 1 and Part 2: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Sampling (AUC0-tlast) of Peposertib
研究概览
简要总结
The study will investigate the effect of food on the Pharmacokinetic (PK) of a single dose of peposertib administered as film-coated tablet under fed and fasted conditions. Furthermore, the PK profile of peposertib administered as an oral suspension of disintegrated tablets and as film-coated tablets will be compared under fasted conditions to evaluate the relative bioavailability in healthy participants.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring
- •Participants are nonsmoker for at least 6 months prior to Screening
- •Participants have a body weight greater than 50 kilogram (kg) and a body mass index within the range 18.5 to 30.0 kilogram per meter square (inclusive) at Screening
- •Male participants are refrain from donating sperm plus either abstain from any activity that allows for exposure to ejaculate
- •Female participants are not pregnant or breastfeeding
- •Other protocol defined inclusion criteria could apply
排除标准
- •History of clinically relevant renal, cardiovascular, pulmonary disease, or endocrinology disorder at Screening
- •History of clinically relevant gastrointestinal disease, in particular pancreatic disease, cholecystitis, liver diseases or hepatic dysfunction at Screening
- •History of psychiatric or relevant neurological disorders (example, depression, epilepsy) at Screening
- •History of relevant skin and mucosal diseases (rash, mucositis) at Screening
- •Presence or history of any serious allergy (requiring hospitalization or prolonged systemic treatment) at Screening
- •Any planned radiologic assessments during the study conduct phase
- •Participants who are not able or willing to eat the entire study meals.
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Part 1: Peposertib: Treatment Sequence A-B-C
Participants will receive single oral dose of peposertib tablet (Treatment A) on Day 1 under fasted condition in period 1, followed by single oral dose of peposertib tablet (Treatment B) on Day 8 under fed condition in period 2, followed by oral suspension dose of peposertib (Treatment C) on Day 15 under fasted condition in period 3. There will be washout period of 7 days between each treatment period.
干预措施: Peposertib (Drug)
Part 1: Peposertib Treatment Sequence A-C-B
Participants will receive single oral dose of peposertib tablet (Treatment A) on Day 1 under fasted condition in period 1, followed by oral suspension dose of peposertib (Treatment C) on Day 8 under fasted condition in period 2, followed by single oral dose of peposertib tablet (Treatment B) on Day 15 under fed condition in period 3. There will be washout period of 7 days between each treatment period.
干预措施: Peposertib (Drug)
Part 1: Peposertib Treatment Sequence B-A-C
Participants will receive single oral dose of peposertib tablet (Treatment B) on Day 1 under fed condition in period 1, followed by single oral dose of peposertib tablet (Treatment A) on Day 8 under fasted condition in period 2, followed by oral suspension dose of peposertib (Treatment C) on Day 15 under fasted condition in period 3. There will be washout period of 7 days between each treatment period.
干预措施: Peposertib (Drug)
Part 1: Peposertib Treatment Sequence B-C-A
Participants will receive single oral dose of peposertib tablet (Treatment B) on Day 1 under fed condition in period 1, followed by oral suspension dose of peposertib (Treatment C) on Day 8 under fasted condition in period 2, followed by single oral dose of peposertib tablet (Treatment A) on Day 15 under fasted condition in period 3. There will be washout period of 7 days between each treatment period.
干预措施: Peposertib (Drug)
Part 1: Peposertib: Treatment Sequence C-A-B
Participants will receive oral suspension dose of peposertib (Treatment C) on Day 1 under fasted condition in period 1, followed by single oral dose of peposertib tablet (Treatment A) on Day 8 under fasted condition in period 2, followed by single oral dose of peposertib tablet (Treatment B) on Day 15 under fed condition in period 3. There will be washout period of 7 days between each treatment period.
干预措施: Peposertib (Drug)
Part 1: Peposertib Treatment Sequence C-B-A
Participants will receive oral suspension dose of peposertib (Treatment C) on Day 1 under fasted condition in period 1, followed by single oral dose of peposertib tablet (Treatment B) on Day 8 under fed condition in period 2, followed by single oral dose of peposertib tablet (Treatment A) on Day 15 under fasted condition in period 3. There will be washout period of 7 days between each treatment period.
干预措施: Peposertib (Drug)
Part 2: Peposertib Treatment Sequence A-B
Participants will receive single oral dose of peposertib tablet (Treatment A) on Day 1 under fasted condition in period 1, followed by single oral dose of peposertib tablet (Treatment B) on Day 8 under fed condition in period 2. There will be washout period of 7 days between each treatment period.
干预措施: Peposertib (Drug)
Part 2: Peposertib: Treatment Sequence B-A
Participants will receive single oral dose of peposertib tablet (Treatment B) on Day 1 under fed condition in period 1, followed by single oral dose of peposertib tablet (Treatment A) on Day 8 under fasted condition in period 2. There will be washout period of 7 days between each treatment period.
干预措施: Peposertib (Drug)
结局指标
主要结局
Part 1 and Part 2: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Sampling (AUC0-tlast) of Peposertib
时间窗: Pre-dose up to 36 hours post-dose
Part 1 and Part 2: Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC-inf) of Peposertib
时间窗: Pre-dose up to 36 hours post-dose
Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) of Peposertib
时间窗: Pre-dose up to 36 hours post-dose
次要结局
- Part 1 and Part 2: Number of Participants With Treatment -Emergent Adverse Events (TEAEs) Based on Severity According to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0(Part 1: up to 21 days; Part 2: up to 14 days)
- Part 1 and Part 2: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Findings(Part 1: up to 21 days; Part 2: up to 14 days)
- Part 1 and Part 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs(Part 1: up to 21 days; Part 2: up to 14 days)