A PHASE 1, OPEN-LABEL, SINGLE DOSE STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF ZAVEGEPANT INTRANASAL ADMINISTRATION IN HEALTHY CHINESE ADULT PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
研究概览
简要总结
The purpose of this study is to learn about:
- how Zavegepant is changed and removed from the body after taken.
- safety of Zavegepant.
- the extent to which side effects can be tolerated after taking Zavegepant for the possible short-term treatment of migraine.
This study is seeking participants who:
- are healthy Chinese adults and includes participants who are between 18 to 55 years old.
- have body mass index (BMI) of 18 to 30 kg/m^2.
- have a total body weight of:
- equal to or more than 50 kilograms (110 pounds) for males.
- equal to or more than 45 kilograms (99 pounds) for females.
- are non-smoker (no use of tobacco or nicotine products).
All participants in this study will receive Zavegepant by nose, once at the study clinic.
The experiences of the participants receiving the study medicine will be looked at. This will help see if the study medicine is safe.
Participants will take part in this study for around 9 weeks. During this time, participants will have 2 study visits at the study clinic and 1 contact over the phone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Healthy Chinese adults and includes participants who are between 18 to 55 years old
- •BMI of 18 to 30 kg/m^2; and a total body weight ≥50 kg (110 lb) for males and ≥45 kg (99 lb) for females
- •Non-smoker (no use of tobacco or nicotine products).
排除标准
- •Evidence or history of clinically significant disease.
- •Use of medication other than topical products without significant systemic absorption.
- •Previous participantion in a clinical research study or investigational study prior to the first dosing.
- •Any clinically significant abnormal laboratory test results or positive test.
- •Evidence of organ dysfunction or any clinically significant deviation from normal.
- •Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic).
- •Standard 12-lead ECG that demonstrates clinically relevant abnormalities.
- •Abnormalities in clinical laboratory tests: AST or ALT level > ULN; Total bilirubin level > ULN; ANC or ALC level > ULN.
- •Positive urine drug screen, alcohol breath test, or urine cotinine test.
- •Positive pregnancy test.
- •Positive result for COVID-
- •History of significant alcohol abuse or drug abuse.
- •History of anaphylaxix reaction or a clinically important reaction to any drug.
- •Donation of plasma within 30 days prior to dosing. Donation or loss of blood of approximately 400 mL or more within 60 days prior to dosing.
- •Inability to be venipunctured and/or tolerate catheter venous access.
- •Habitual use of snuff tobacco.
- •History of sensitivity to heparin or heparin-induced thrombocytopenia.
研究组 & 干预措施
Zavegepant
Participants receiving Zavegepant for the treatment phase of the study
干预措施: Zavegepant (Drug)
结局指标
主要结局
Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
时间窗: 0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1
Maximum plasma concentration (Cmax) was measured.
AUClast of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
时间窗: 0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1
AUClast, area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast), was measured.
AUCinf of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
时间窗: 0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1
AUCinf, area under the plasma concentration-time curve from time 0 extrapolated to infinite time, was measured.
次要结局
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Day 1 up to maximum of 35 days post single dose administration)
- Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)(Day 1 up to maximum of 35 days post single dose administration)
- Number of Participants With Clinically Significant Values of Vital Signs(Day 1 up to maximum of 35 days post single dose administration)
- Number of Participants With Clinically Significant Values of 12-lead ECGs(Day 1 up to maximum of 35 days post single dose administration)
- Tmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN(0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1)
- t1/2 of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN(0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1)
- CL/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN(0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1)
- Vz/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN(0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1)