A Phase 1, Open-Label, Randomized, Two-Way Crossover Study to Evaluate the Effect of Single-Dose Intravenous Rifampin as a Prototypic Inhibitor of OATP1B1 and OATP1B3 on the Single-Dose Pharmacokinetics of Oral TAK-906 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906
研究概览
简要总结
The purpose of this study is to evaluate the effect of single dose intravenous rifampin on the single-dose PK of orally administered TAK-906.
详细描述
The drug being tested in this study is called TAK-906. TAK-906 is being tested to evaluate the effect of single dose intravenous rifampin on the single-dose PK of oral TAK-906 in healthy adult participants.
The study will enroll approximately 12 participants. Participants will be randomly assigned to one of the two treatment sequences AB or BA:
- Sequence AB: TAK-906 25 mg, followed by a washout period of at least 7 days, then Rifampin 600 mg and TAK-906 25 mg
- Sequence BA: Rifampin 600 mg and TAK-906 25 mg, followed by a washout period of at least 7 days, then TAK-906 25 mg
This single center trial will be conducted in the United States. The overall time to participate in this study is 49 Days. All participants will make final visit 14 days after receiving their last dose of study drug for 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 3 months prior to the first dosing and throughout the study, based on screening urine cotinine test.
- •Body Mass Index (BMI) greater than or equal to (>=) 18.0 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 ECGs, as deemed by the investigator or designee.
排除标准
- •Positive urine drug or alcohol results at screening and each check in.
- •Positive urine cotinine at screening.
- •Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- •QT interval with Fridericia's correction (QTcF) interval is >450 millisecond (msec) or ECG findings are deemed abnormal with clinical significance by the investigator or designee at screening.
- •Estimated creatinine clearance <90 milliliter per minute (mL/min) at screening.
- •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 (example, approximately 500 milliliter [mL]) 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 AB: TAK-906 25 mg + TAK-906 25 mg and Rifampin 600 mg
TAK-906 25 milligram (mg) (Treatment A), capsule, orally, once on Day 1 of Study Period 1, followed by a washout period of at least 7 days, further followed by rifampin 600 mg, infusion, once, intravenously over 30 minutes along with TAK-906 25 mg (Treatment B), capsule, orally, once immediately after the end of infusion on Day 1 of Study Period 2.
干预措施: TAK-906 (Drug)
Sequence AB: TAK-906 25 mg + TAK-906 25 mg and Rifampin 600 mg
TAK-906 25 milligram (mg) (Treatment A), capsule, orally, once on Day 1 of Study Period 1, followed by a washout period of at least 7 days, further followed by rifampin 600 mg, infusion, once, intravenously over 30 minutes along with TAK-906 25 mg (Treatment B), capsule, orally, once immediately after the end of infusion on Day 1 of Study Period 2.
干预措施: Rifampin (Drug)
Sequence BA: TAK-906 25 mg and Rifampin 600 mg + TAK-906 25 mg
Rifampin 600 mg, infusion, once, intravenously over 30 minutes along with TAK-906 25 mg (Treatment B), capsule, orally, once immediately after the end of infusion on Day 1 of Study Period 1 followed by a washout period of at least 7 days, further followed by TAK-906 25 mg (Treatment A), capsule, orally, once on Day 1 of Study Period 2.
干预措施: TAK-906 (Drug)
Sequence BA: TAK-906 25 mg and Rifampin 600 mg + TAK-906 25 mg
Rifampin 600 mg, infusion, once, intravenously over 30 minutes along with TAK-906 25 mg (Treatment B), capsule, orally, once immediately after the end of infusion on Day 1 of Study Period 1 followed by a washout period of at least 7 days, further followed by TAK-906 25 mg (Treatment A), capsule, orally, once on Day 1 of Study Period 2.
干预措施: Rifampin (Drug)
结局指标
主要结局
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906
时间窗: Day 1: time zero and at multiple time points (up to 48 hours) post dose
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906
时间窗: Day 1: time zero and at multiple time points (up to 48 hours) post dose
Cmax: Maximum Observed Plasma Concentration for TAK-906
时间窗: Day 1: time zero and at multiple time points (up to 48 hours) post dose
次要结局
- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)(Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23))
- Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings(Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23))
- Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values(Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23))
- Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values(Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23))