A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Multiple Oral Doses of Fluconazole and Atorvastatin on the Pharmacokinetics of a Single Oral Dose of TAK-385 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 1
研究概览
简要总结
This is a nonrandomized, open-label, fixed-sequence, 2-arm study designed to assess the effect of multiple doses of fluconazole or atorvastatin on the single-dose pharmacokinetics of TAK-385 in healthy adult subjects.
详细描述
The drug being tested in this study is called TAK-385. TAK-385 was being tested to assess if the way it is processed the body changes when it administered with other medications (fluconazole or atorvastatin). This study looked at lab results in people who took TAK-385.
The study enrolled 40 patients. Participants were assigned to one of the two treatment groups:
- TAK-385 40 mg and fluconazole 400 mg on Day 6 and 200 mg on Days 7 to 14
- TAK-385 40 mg and atorvastatin 80 mg on Days 6-14
Participants in the fluconazole arm were administered TAK-385 on Days 1 and 10 and fluconazole on Days 6 through 14. Participants in the atorvastatin arm were administered TAK-385 on Days 1 and 10 and atorvastatin on Days 6 through 14.
This single-center trial was conducted in the United States. The overall time to participate in this study was 4 weeks. Participants made multiple visits to the clinic, including one 16-day period of confinement to the clinic, and a final visit 7 days after last dose of study drug for a follow-up assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 未提供
研究组 & 干预措施
TAK-385 + atorvastatin
TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on Days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on Day 10 then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
干预措施: Atorvastatin (Drug)
TAK-385 + fluconazole
TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on Day 10 then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
干预措施: TAK-385 (Drug)
TAK-385 + fluconazole
TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on Day 10 then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
干预措施: Fluconazole (Drug)
TAK-385 + atorvastatin
TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on Days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on Day 10 then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
干预措施: TAK-385 (Drug)
结局指标
主要结局
Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 1
时间窗: Day 1 (Predose and multiple time points up to 120 hours postdose)
Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 10
时间窗: Day 10 (Predose and multiple time points up to 120 hours postdose)
Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 1
时间窗: Day 1 (Predose and multiple time points up to 120 hours postdose)
Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration.
AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 1
时间窗: Day 1 (Predose and multiple time points up to 120 hours postdose)
Area under the plasma concentration-time curve from time 0 to infinity.
AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 10
时间窗: Day 10 (Predose and multiple time points up to 120 hours postdose)
Area under the plasma concentration-time curve from time 0 to infinity.
AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 10
时间窗: Day 10 (Predose and multiple time points up to 120 hours postdose)
Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration.
次要结局
- Number of Participants With Clinical Significant Changes in Electrocardiogram (ECG) Findings(Baseline and First dose of study drug through Day 15)
- Apparent Total Body Clearance (CL/F) of TAK-385(Days 1 and 10 (Predose and multiple time points up to 120 hours postdose))
- Fraction Excreted Unchanged (Fe) of TAK-385(Days 1 and 10 (Predose and multiple time points up to 120 hours postdose))
- Number of Participants With at Least 1 Treatment Emergent Adverse Event (AE)(First dose of study drug through the end of the study (22 days ± 3 days))
- Number of Participants With Clinical Significant Changes in Vital Signs(Baseline and First dose of study drug through the end of the study (22 days ± 3 days))
- Number of Participants With Clinical Significant Changes in Laboratory Tests(Baseline and First dose of study drug through the end of the study (22 days ± 3 days))
- Tmax: Time to Reach the Maximum Plasma Concentration of TAK-385(Days 1 and 10 (Predose and multiple time points up to 120 hours postdose))
- AUC (0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours of TAK-385(Days 1 and 10 (Predose and multiple time points up to 120 hours postdose))
- Terminal Disposition Half-life (t1/2) of TAK-385(Days 1 and 10 (Predose and multiple time points up to 120 hours postdose))
- Plasma Trough Concentrations for Fluconazole(Days 8 to 12 Predose)
- Plasma Trough Concentrations for Atorvastatin(Days 8 to 12 Predose)