A Phase 1, Open-Label, Randomized, Single-Dose, Parallel-Group Study to Evaluate the Food Effect on the Pharmacokinetics of TP-05 Under Fed and Fasted Conditions in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Concentration of TP-05 in whole blood
研究概览
简要总结
A Phase 1, Open-Label, Randomized, Single-Dose, Parallel-Group Study to Evaluate the Food Effect on the Pharmacokinetics of TP-05 under Fed and Fasted Conditions in Healthy Participants.
详细描述
This is a Phase 1, open-label, randomized, single-dose, parallel-group study to evaluate the food effect on the pharmacokinetics of TP-05 under fed and fasted conditions in healthy participants.
The study will consist of a screening period of up to 28 days. Participants who are eligible for the study will check into the clinical research site on Day -1. All participants will undergo an overnight fast of at least 10.5 hours prior to dosing. On Day -1 participants will be randomized to receive one of three treatment regimens on Day 1: single dose of TP-05, fasted; single dose of TP-05 following a high-fat breakfast; or single dose of TP-05 following a low-fat breakfast.
Participants will be resident at the clinical research site from Day -1 until completion of assessments at 96 hours post-dose (Day 5) and return on Day 60 for a follow-up visit. Participants will complete a telephone safety follow-up visit at Day 120.
Safety will be assessed by adverse events, vital signs, performing physical examinations, electrocardiograms, and evaluating clinical laboratory results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 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 medical evaluation including medical history and physical examination
- •Participants who are non- or ex-smokers
- •No clinically significant disease captuired in medical history or evidence of clinically significant findings on the physical examination and/or ECG at Screening and Day -1, as determined by the Investigator
- •BMI 18.5-29.9 kg/m2 (inclusive) and weighs at least 50.0 kg at Screening
- •Ability to comply with contraceptive requirements
排除标准
- •Female who is breast-feeding or pregnancy according to the serum pregnancy test at Screening and urine pregnancy test at Day -1 prior to study drug administration
- •History of significant hypersensitivity to lotilaner or any related products
- •History of significant gastrointestinal, metabolic, liver, or kidney disease, or surgery that may affect drug bioavailability
- •History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease
- •History of malignancy (or active malignancy), with the exception of treated basal cell or squamous cell carcinoma
- •Positive test results for HIV-1/HIV-2 antigen/antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibody (HCVAb)
- •Positive result for SARS-CoV-2 testing at Day -1
- •Use of any non-prescription or prescription drugs in the 7 days or 5 half-lives (whichever is longer) prior to study drug administration and through the treatment period of the study
- •Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to Screening and through Day 60 of the study
- •History of live attenuated vaccine within 4 weeks prior to study drug administration or requirement to receive these vaccinations through Day 60 of the study
- •Plasma donation within 7 days prior to Screening through Day 60 of the study
- •Blood donation or significant blood loss approximately 500 mL within 56 days prior to Screening through Day 60 of the study
研究组 & 干预措施
TP-05, Fasted Group
Single dose of TP-05 (lotilaner oral), fasted
干预措施: TP-05 (lotilaner oral), fasted group (Drug)
TP-05, High-Fat Group
Single dose of TP-05 (lotilaner oral) following a high-fat meal
干预措施: TP-05 (lotilaner oral), high-fat group (Drug)
TP-05, Low-Fat Group
Single dose of TP-05 (lotilaner oral) following a low-fat meal
干预措施: TP-05 (lotilaner oral), low-fat group (Drug)
结局指标
主要结局
Concentration of TP-05 in whole blood
时间窗: Up to Day 60
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes concentration level.
Exposure and PK of lotilaner in whole blood (Tmax)
时间窗: Up to Day 60
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes Tmax.
Exposure and PK of lotilaner in whole blood (AUC0-96hours)
时间窗: Up to Day 5
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes AUC0-96hours.
Exposure and PK of lotilaner in whole blood (Cmax)
时间窗: Up to Day 60
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes Cmax.
Exposure and PK of lotilaner in whole blood (Tlag)
时间窗: Up to Day 60
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes Tlag.
次要结局
- Clinically significant changes from Baseline physical examination(Up to Day 60)
- Clinically significant changes from Baseline chemistry laboratory tests(Up to Day 60)
- Incidence of treatment emergent adverse events (TEAEs)(Up to Day 120)
- Clinically significant changes from Baseline vital signs(Up to Day 60)
- Clinically significant changes from Baseline electrocardiograms (ECGs)(Up to Day 60)