A PHASE 1, OPEN-LABEL, SINGLE DOSE, FIXED-SEQUENCE CROSSOVER SUB STUDY TO DETERMINE THE PHARMACOKINETICS USING TASSO DEVICE AND SAFETY AND TOLERABILITY USING WEARABLE MONITORING DEVICES FOLLOWING SINGLE ORAL DOSES OF ETRASIMOD 2 MG IR TABLETS IN HEALTHY ADULT PARTICIPANTS IN A HYBRID DECENTRALIZED CLINICAL TRIAL DESIGN
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Area Under the Serum Concentration-Time Profile From Time Zero to 24 Hours (AUC0-24) of Etrasimod: Tasso PK Sampling
研究概览
简要总结
The purpose of this study is to look at how healthy adults process Etrasimod when assessed by wearable sensors. Etrasimod is taken without food and assessments taken by site staff and then by participants after training.
The study is seeking participants who are:
- Aged 18 or older
- Male or female who are healthy as determined by medical assessment
- Body-mass index (BMI) of 16 to 32, and a total body weight > 50kg.
The study will take up to 9 weeks, including the screening period. Participants will have to stay at the study clinic for at least 2 nights, in each of 2 study periods.
Participants will take Etrasimod as a tablet by mouth without food. Blood samples will be taken both before and after participants take Etrasimod. Participants will also use wearable devices to assess blood pressure, heart rate and take further blood samples. A follow-up phone call will be made 20 to 27 days after the last study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants
- •BMI 16 to 32 kg/m2
- •body weight more than 50kg
排除标准
- •Ongoing or past history of significant medical conditions
- •Eye disorders such as macular edema or uveitis
- •Ongoing or recent infections
- •Use of prescription or non prescription medications within 7 days of first dose
- •Smoking or using nicotine products equivalent to more than 5 cigarettes per day
- •History of severe allergic or anaphylactic reactions
研究组 & 干预措施
Fixed Sequence
Single oral dose of etrasimod 2mg tablet under fasted conditions with site staff led assessments and training on how to use wearable sensors followed by single oral dose 2mg tablet under fasted conditions with participant led assessments with wearable sensors.
干预措施: Etrasimod Immediate Release (IR) (Drug)
结局指标
主要结局
Area Under the Serum Concentration-Time Profile From Time Zero to 24 Hours (AUC0-24) of Etrasimod: Tasso PK Sampling
时间窗: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 of each period
AUC0-24 was calculated as linear/log trapezoidal method. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by clinical research unit (CRU) staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
Area Under the Serum Concentration-Time Profile From Time 24 Hours to the Time of the Last Quantifiable Concentration (AUC24hr-last) of Etrasimod: Tasso PK Sampling
时间窗: 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period
AUC24hr-last was calculated as linear/log trapezoidal method. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod: Tasso PK Sampling
时间窗: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period
AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast is area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). Clast is the predicted plasma concentration at the last quantifiable time point and Kel is the terminal phase rate constant. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
Maximum Observed Concentration (Cmax) of Etrasimod: Tasso PK Sampling
时间窗: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period
PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
次要结局
- AUC24hr-last of Etrasimod: Tasso and Venous PK Sampling(24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period)
- AUCinf for Etrasimod: Tasso and Venous PK Sampling(Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period)
- Cmax for Etrasimod: Tasso and Venous PK Sampling(Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period)
- Change From Baseline in Heart Rate (HR) at 1, 2, 3, 4 ,5, 6, 8 and 24 Hours Post-dose on Day 1(Baseline; 1, 2, 3 ,4, 5, 6, 8 and 24 hours post-dose on Day 1 of each period)
- Change From Baseline to Nadir in HR at Day 1(Baseline; Anytime or latest time with minimum HR measurement taken post-dose on Day 1 of each period)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days))
- Number of Participants With Clinically Significant Findings in Laboratory Abnormalities(Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days))
- Number of Participants With Clinically Significant Findings in Vital Signs(Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days))
- Number of Participants With Clinically Significant Findings in Physical Examination(Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days))
- Number of Participants Categorized Per Pre-defined Electrocardiogram (ECG) Findings Criteria(From Baseline (Day 1) maximum up to Day 17)
- AUC0-24 of Etrasimod: Tasso and Venous PK Sampling(Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 of each period)