A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, 3-Period, Incomplete Block Design Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-954 in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) for TAK-954
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and PK of single ascending intravenous doses of TAK-954.
详细描述
The drug being tested in this study is called TAK-954. This study will assess the safety, tolerability, PK and PD of single ascending TAK-954 higher intravenous doses than those previously studied.
The study will enroll approximately 6 participants. Participants will be randomly assigned (By chance, like flipping a coin) to one of the three treatment sequences-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).
In each treatment sequence, each participant will receive 2 doses of active drug out of 3 dose levels (TAK-954 0.5 mg, TAK-954 1 mg, or TAK-954 2 mg) and 1 dose of Placebo. Dose escalation will be based on the available safety/tolerability data from the previous period.
This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 73 days. Participants will make a final visit on Day 16 after receiving their 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
- Double (Participant, Investigator)
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
- •Body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to (<=) 32 kilogram per square meter (kg/m^2), weighing >=50 kilogram (kg) at screening.
- •Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, orthostatic vital signs, or ECGs, as deemed by the Investigator or designee.
- •Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dose and throughout the study, based on participant self-reporting.
排除标准
- •History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- •Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing.
- •Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 2 weeks of first dosing.
研究组 & 干预措施
Sequence 1
Period 1: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2.
Period 2: TAK-954 0.1 milligram (mg), infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 1 mg infusion, administered intravenously over 60-minutes, once on Day 2.
Period 3: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 2 mg infusion, administered intravenously over 60-minutes, once on Day 2.
A washout period of at least 16 days will be maintained between each Treatment Period.
干预措施: TAK-954 (Drug)
Sequence 1
Period 1: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2.
Period 2: TAK-954 0.1 milligram (mg), infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 1 mg infusion, administered intravenously over 60-minutes, once on Day 2.
Period 3: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 2 mg infusion, administered intravenously over 60-minutes, once on Day 2.
A washout period of at least 16 days will be maintained between each Treatment Period.
干预措施: TAK-954 Placebo (Drug)
Sequence 2
Period 1: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 0.5 mg infusion, administered intravenously over 60-minutes once on Day 2.
Period 2: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2.
Period 3: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 2 mg, infusion, administered intravenously over 60-minutes, once on Day 2.
A washout period of at least 16 days will be maintained between each Treatment Period.
干预措施: TAK-954 (Drug)
Sequence 2
Period 1: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 0.5 mg infusion, administered intravenously over 60-minutes once on Day 2.
Period 2: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2.
Period 3: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 2 mg, infusion, administered intravenously over 60-minutes, once on Day 2.
A washout period of at least 16 days will be maintained between each Treatment Period.
干预措施: TAK-954 Placebo (Drug)
Sequence 3
Period 1: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 0.5 mg, infusion, administered intravenously over 60-minutes once on Day 2.
Period 2: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 1 mg, infusion, administered intravenously over 60-minutes, once on Day 2.
Period 3: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2. A washout period of at least 16 days will be maintained between each Treatment Period.
干预措施: TAK-954 (Drug)
Sequence 3
Period 1: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 0.5 mg, infusion, administered intravenously over 60-minutes once on Day 2.
Period 2: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 1 mg, infusion, administered intravenously over 60-minutes, once on Day 2.
Period 3: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2. A washout period of at least 16 days will be maintained between each Treatment Period.
干预措施: TAK-954 Placebo (Drug)
结局指标
主要结局
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) for TAK-954
时间窗: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
Number of Participants With Clinically Notable Shifts From Baseline to Abnormal Post-dose in Clinical Laboratory Values for TAK-954
时间窗: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs for TAK-954
时间窗: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) for TAK-954
时间窗: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954
时间窗: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954
时间窗: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose
Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-954
时间窗: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose
CL: Total Clearance After Intravenous Administration for TAK-954
时间窗: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose
Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-954
时间窗: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose
Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 12 Hours Post-dose
时间窗: Day 2 pre-dose and at multiple time points (up to 12 hours) post-dose
Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 24 Hours Post-dose
时间窗: Day 2 pre-dose and at multiple time points (up to 24 hours) post-dose
Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 24 Hours Post-dose
时间窗: Day 2 pre-dose and at multiple time points (up to 24 hours) post-dose
CLR: Renal Clearance for TAK-954
时间窗: Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose
Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 36 Hours Post-dose
时间窗: Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose
Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 12 Hours Post-dose
时间窗: Day 2 pre-dose and at multiple time points (up to 12 hours) post-dose
Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 36 Hours Post-dose
时间窗: Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose
次要结局
- Number of Participants With First Stool of TAK-954 Within 36 Hours Post-dose on Day 2(Day 2 dosing and at multiple time points (up to 36 hours) post-dose)
- Mean Number of Stools of TAK-954 Within 36 Hours Post-dose on Day 2(Day 2 dosing and at multiple time points (up to 36 hours) post-dose)
- Instances of Stool Type of TAK-954 Based on Bristol Stool Form Scale(Day 2 dosing and at multiple time points (up to 36 hours) post-dose)