A single-dose study of zavegepant in healthy male volunteers

Phase 1

Completed

• Conditions: Migraine; Nervous System Diseases

• Registration Number: ISRCTN19930942
• Lead Sponsor: Biohaven Pharmaceuticals (United States)

Brief Summary

2022 Abstract results in https://doi.org/10.1111/head.14317 (added 15/07/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-08-28
• Study Start: 2022-04-01
• Last Update Posted: 5 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

1. Must provide written informed consent prior to any study-related procedures
2. Healthy males
3. Age 30 to 60 years of age inclusive at the time of signing informed consent
4. Body mass index (BMI) of 18.0 to 32.0 kg/m² as measured at screening
5. Subject’s score on the Sheehan Suicidality Tracking Scale (S-STS) test must be 0
6. Must be able to understand the requirements of the study, and willing and able to communicate and comply with all study procedures
7. Must have regular bowel movements (i.e. average stool production of =1 and =3 stools per day)
8. Must agree to adhere to the contraception requirements

Exclusion Criteria

1. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
2. Subjects who are, or are immediate family members of a study site or sponsor employee
3. Subjects who have previously been administered IMP in this study
4. History of any drug or alcohol abuse in the past 2 years
5. Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, or a 25 ml shot of 40% spirit, 1.5 to 2 units = 125 ml glass of wine, depending on type)
6. A confirmed positive alcohol breath test at screening or admission
7. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
8. Current smokers and those who have smoked within the last 12 months and/or current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
9. Subjects with partners who are pregnant or lactating or planning to become pregnant during the study ore within 90 days after study drug administration
10. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other therapeutic medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
11. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening/pre-dose
12. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are allowed.
13. Confirmed positive drugs of abuse test result at screening or admission
14. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
15. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of <80 mL/min using the Cockcroft-Gault equation
16. History of clinically significant cardiovascular, renal, hepatic, pulmonary, gastrointestinal, hematologic, neoplastic, endocrine, immunological, neurological or psychiatric disease or disorder, as judged by the investigator
17. History of clinically significant illness and surgery within 4 weeks prior to dosing. Subjects vomiting within 24 h pre-dose will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the investigator.
18. Significant history of seizure disorder other than a single childhood febrile seizure (e.g. epilepsy)
19. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
20. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
21. Donation or loss of greater than 400 ml of blood within the previous 3 months
22. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies or dietary supplements (other than up to 4 g of paracetamol per day) in the 14 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the investigator.
23. Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first drug administration.
24. Any of the following laboratory parameters above the upper limit of

Study & Design

• Study Type: Interventional
• Study Design: Not specified