A Phase 1, Randomized, 2-Period, 2-Sequence, Crossover Study to Evaluate the Effect of High-Fat Meal on TAK-788 Pharmacokinetics in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib
研究概览
简要总结
The purpose of this study is to characterize the effect of a high-fat meal on the PK of TAK-788 administered in healthy participants.
详细描述
The drug being tested in this study is called TAK-788. The study will characterize the effect of a high-fat meal on the PK of TAK-788 administered in healthy participants.
The study will enroll approximately 14 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment sequence
- TAK-788 160 mg Fasted (Reference) in Period 1 + TAK-788 160 mg Fed (Test) in Period 2
- TAK-788 160 mg Fed (Test) in Period 1 + TAK-788 160 mg Fasted (Reference) in Period 2
All participants will be asked to take capsules of assigned TAK-788 on Day 1 of each period.
This single-center trial will be conducted in the United States. The overall time to participate in this study is 61 days. Participants will be contacted by telephone for 30 days after the last dose of study drug for a follow-up assessment.
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
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Continuous non-smoker who has not used nicotine-containing products for at least 20 years prior to the first dosing and throughout the study, based on participant self-reporting.
- •Body mass index (BMI) greater than or equal to (>=) 18.5 and less than or equal to (<=) 30.0 kilogram per square meter (kg/m^2), at screening.
- •Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or electrocardiogram (ECGs), as deemed by the Investigator or designee.
排除标准
- •History of any illness (including hyperlipidemia and diabetes since high fat meal is required) that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- •History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- •History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
- •History or presence of any previous lung disease and/or current lung infection.
- •Positive urine drug or alcohol results at screening or first check-in.
- •Positive results at screening for Human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV).
- •Positive test result for active coronavirus disease 2019 (COVID-19).
- •Seated blood pressure is less than (<) 90/40 millimeter of mercury of mercury (mmHg) or greater than 140/90 mmHg at screening.
- •Seated heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening.
- •QT interval corrected for heart rate using Fridericia's formula (QTcF) interval is greater than (>) 460 millisecond (msec) (males) or >470 msec (females) or ECG findings are deemed abnormal with clinical significance by the Investigator or designee at screening.
- •Creatinine clearance <90 milliliter per minute (mL/min) at screening (calculated using the Cockcroft-Gault formula).
- •Unable to refrain from or anticipates the use of:
- •o Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study. Medication listed as part of acceptable birth control methods will be allowed. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to the first dosing.
- •Acetaminophen (up to 2 gram per 24 hour period) may be permitted during the study, only after initial dosing, if necessary, to treat adverse events (AEs).
- •o Any drugs known to be inhibitors or inducers of Cytochrome P450 (CYP3A) enzymes and/or P-glycoprotein (P-gp), including St. John's Wort, within 28 days prior to the first dosing and throughout the study.
- •Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study.
- •Donation of blood or significant blood loss within 56 days prior to the first dosing.
- •Plasma donation within 7 days prior to the first dosing.
研究组 & 干预措施
TAK-788 160 mg Fasted + TAK-788 160 mg Fed
TAK-788 160 milligram (mg), capsule, orally, once on Day 1 of Period 1 under fasted conditions (Treatment A), followed by 10 days washout period, followed by TAK-788 160 mg, capsule, orally, once on Day 1 of Period 2 under fed conditions (Treatment B).
干预措施: TAK-788 (Drug)
TAK-788 160 mg Fed + TAK-788 160 mg Fasted
TAK-788 160 mg, capsule, orally, once on Day 1 of Period 1 under fed conditions (Treatment B), followed by 10 days washout period, followed by TAK-788 160 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions (Treatment A).
干预措施: TAK-788 (Drug)
结局指标
主要结局
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib
时间窗: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for Mobocertinib
时间窗: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib
时间窗: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib
时间窗: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
次要结局
- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Active Metabolites (AP32960 and AP32914) of Mobocertinib(Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose)
- Cmax: Maximum Observed Plasma Concentration for Active Metabolites (AP32960 and AP32914) of Mobocertinib(Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose)
- AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Active Metabolites (AP32960 and AP32914) of Mobocertinib(Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose)
- AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Active Metabolites (AP32960 and AP32914) of Mobocertinib(Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose)