A Randomized, Open-label, Single-dose, Three-way Crossover Evaluation of the Effect of Food on the Pharmacokinetics, Safety, and Tolerability of TAK-227 in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax: Maximum Observed Plasma Concentration for TAK-227
研究概览
简要总结
The main aim of this study is to test the effects of food consumption with sponsor compound TAK-227 in healthy participants. The study will also measure side effects, and to check how much TAK-227 stays in the blood over time to work out the best dose.
详细描述
The drug being tested in this study is called TAK-227. This study will assess the effect of food on single-dose of TAK-227 in healthy participants.
The study will enroll approximately 24 participants. A single dose of 50 milligram (mg) TAK-227 will be administered orally under one of 3 different feeding conditions.
- Fasting (Treatment A),
- Fed following a high-fat or high-calorie meal prior to dosing (Treatment B), and
- Fed following a high-fat or high-calorie meal after dosing (Treatment C)
Participants will be randomly assigned to 1 of the 6 treatments sequences based on the 3 feeding conditions.
- Sequence 1: (Treatment A + Treatment B + Treatment C)
- Sequence 2: (Treatment B + Treatment C + Treatment A)
- Sequence 3: (Treatment C + Treatment A + Treatment B)
- Sequence 4: (Treatment A + Treatment C + Treatment B)
- Sequence 5: (Treatment B + Treatment A + Treatment C)
- Sequence 6: (Treatment C + Treatment B + Treatment A)
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
- 未提供
排除标准
- •Participants must not be enrolled in the study if they meet any of the following criteria:
- •Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- •Drink alcohol in excess of 21 units per week for males or 14 units per week for females, with one unit equal to (=) 150 milliliter (mL) of wine or 360 mL of beer or 45 mL of 45 percent (%) alcohol.
- •Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- •Unable to refrain from or anticipates the use of:
- •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 first study drug administration. Hormone replacement therapy will also be allowed.
- •Any drugs known to be significant inducers or inhibitors of Cytochrome P450 (CYP)3A4 enzymes and/or P-glycoprotein (gp), including St. John's Wort, within 28 days prior to the first dosing and throughout the study. Appropriate sources (example, Flockhart Table TM) will be consulted to confirm lack of pharmacokinetic (PK)/pharmacodynamics interaction with study drug.
- •Chronic use of non-steroidal anti-inflammatory (define as more that 7 days of use) within 2 weeks prior to screening 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
Sequence 1: (Treatment A + Treatment B + Treatment C)
TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 under fasting condition as Treatment A, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C. There will be a washout period of at least 4 days between each dosing.
干预措施: TAK-227 (Drug)
Sequence 2: (Treatment B + Treatment C + Treatment A)
TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 under fasting condition as Treatment A . There will be a washout period of at least 4 days between each dosing.
干预措施: TAK-227 (Drug)
Sequence 3: (Treatment C + Treatment A + Treatment B)
TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 under fasting condition as Treatment A, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B. There will be a washout period of at least 4 days between each dosing.
干预措施: TAK-227 (Drug)
Sequence 4: (Treatment A + Treatment C + Treatment B)
TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 under fasting condition as Treatment A, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B. There will be a washout period of at least 4 days between each dosing.
干预措施: TAK-227 (Drug)
Sequence 5: (Treatment B + Treatment A + Treatment C)
TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 under fasting condition as Treatment A, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C. There will be a washout period of at least 4 days between each dosing.
干预措施: TAK-227 (Drug)
Sequence 6: (Treatment C + Treatment B + Treatment A)
TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 under fasting condition as Treatment A. There will be a washout period of at least 4 days between each dosing.
干预措施: TAK-227 (Drug)
结局指标
主要结局
Cmax: Maximum Observed Plasma Concentration for TAK-227
时间窗: Day 1 pre-dose and at multiple time points (up to 36 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-227
时间窗: Day 1 pre-dose and at multiple time points (up to 36 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-227
时间窗: Day 1 pre-dose and at multiple time points (up to 36 hours) post-dose
次要结局
- Number of Participants Based on Severity of TEAE(From start of study drug administration up to 7 days after the last dose (up to Day 20))
- Number of Participants With Clinically Significant Change From Baseline in Physical Examination(Baseline to Day 13)
- Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECG) Values(Baseline to Day 13)
- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs(From start of study drug administration up to 7 days after the last dose (up to Day 20))
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values(Baseline to Day 13)
- Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters(Baseline to Day 13)
- Number of Participants Based on Causality of TEAEs(From start of study drug administration up to 7 days after the last dose (up to Day 20))