A Study to Learn About the Study Medicine Called Zavegepant in Healthy Chinese Adult Participants

Study Overview
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Brief Summary
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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.

Official Title
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A PHASE 1, OPEN-LABEL, SINGLE DOSE STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF ZAVEGEPANT INTRANASAL ADMINISTRATION IN HEALTHY CHINESE ADULT PARTICIPANTS

Conditions
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Healthy

Intervention / Treatment
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* Drug: Zavegepant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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-19. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zavegepant<br>Participants receiving Zavegepant for the treatment phase of the study | Drug: Zavegepant<br>* Participants receiving single dose of Zavegepant 10 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) |  | Pre-dose and 5, 10, 20, 30, 40 ,50 mins, and 1, 1.5, 2, 3, 4, 8, 12, 16, 24 hours post-dose | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | Pre-dose and 5, 10, 20, 30, 40 ,50 mins, and 1, 1.5, 2, 3, 4, 8, 12, 16, 24 hours post-dose | 
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). | Pre-dose and 5, 10, 20, 30, 40 ,50 mins, and 1, 1.5, 2, 3, 4, 8, 12, 16, 24 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. AEs included all SAEs and non-SAEs. | From baseline up to 35 days after last dose | 
| Number of Participants With Laboratory Abnormalities | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy[if urine tested positive for blood, protein, nitrites or leukocyte esterase]). | From baseline up to 35 days after last dose | 
| Number of Participants With Clinically Notable Vital Signs | Abnormality in vital signs: Pulse rate <40 beats per minute (bpm) to >120 bpm, Diastolic blood pressure < 50 millimeter of mercury (mmHg), increase and decrease in change from baseline of >= 20mmHg, systolic blood pressure < 90 mmHg, increase and decrease in change from baseline of >= 30mmHg. | From baseline up to 35 days after last dose | 
| Number of Participants With Notable 12-Lead Electrocardiogram (ECG) Values | Criteria for notable ECG values were as follow: corrected QT interval by Fredericia formula (QTcF) in msec new (newly occurring post-baseline value) > 450, 480, 500, increase from baseline >30, increase from baseline >60; PR interval in ms new (newly occurring post-baseline value) >=300, increase from baseline >=25%, increase from baseline >=50%; QRS interval in ms new (newly occurring post-baseline valuew) >=140, increase from baseline >=50%. | From baseline up to 35 days after last dose | 
| Number of Participants With Clinically Significant Findings in Physical Examination | A complete physical examination included the examination of head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination included the examination of general appearance, the respiratory and cardiovascular systems, and participant-reported symptoms. Physical examination abnormalities were as determined by the investigator. | From baseline up to 35 days after last dose | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | Pre-dose and 5, 10, 20, 30, 40 ,50 mins, and 1, 1.5, 2, 3, 4, 8, 12, 16, 24 hours post-dose | 
| Terminal Half-Life (t1/2) | Terminal half-life is the time measured for the plasma concentration to decrease by one half. | Pre-dose and 5, 10, 20, 30, 40 ,50 mins, and 1, 1.5, 2, 3, 4, 8, 12, 16, 24 hours post-dose | 
| Apparent Clearance (CL/F) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. | Pre-dose and 5, 10, 20, 30, 40 ,50 mins, and 1, 1.5, 2, 3, 4, 8, 12, 16, 24 hours post-dose | 
| Apparent Volume of Distribution (Vz/F) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | Pre-dose and 5, 10, 20, 30, 40 ,50 mins, and 1, 1.5, 2, 3, 4, 8, 12, 16, 24 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zavegepant, Healthy volunteer