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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Nand Singh
+44 (0)1159749000
Nand.Singh@quotientsciences.com


Dr Nand Singh
+44 (0)1159749000
Nand.Singh@quotientsciences.com


Dr Nand Singh
+44 (0)1159749000
Nand.Singh@quotientsciences.com


Study Location:

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Be Part of Research - Trial Details - A single-dose study of zavegepant in healthy male volunteers
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A single-dose study of zavegepant in healthy male volunteers

Not Recruiting

Open to: Male

Age: Adult

0.9 Mile Away
Nottingham

Medical Conditions

Migraine

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Zavegepant (also known as BHV-3500) is being developed as a treatment for migraine. The aim of this study is to identify the absorption, distribution, metabolism, and excretion of radiolabeled zavegepant.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

17 Jul 2020 30 Jul 2020

Publications

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

Participants will be screened with blood tests, vital signs, electrocardiogram (ECG), physical examination, and completion of the Sheehan Suicidality Tracking Scale (S-STS) to determine study eligibility. If qualified, participants will return to the clinic to check in the day before dosing is planned. After fasting overnight, on the morning of Day 1, an intravenous (IV) infusion tube will be inserted into the participants’ arms and they will be given a single 5 mg dose of the test drug, 14C-zavegepant solution, by IV over 15 minutes. Participants will stay in the clinic until up to 240 hours after dosing (Day 11). During this time, urine, stool and blood samples will be collected to measure the amount of radioactivity being excreted and the participants will be monitored for any adverse events. Participants will be released as a group when over 90% of the dose of radioactivity administered has been recovered or if less than 1% of the dose administered has been collected in urine and stool within two separate consecutive 24-hour periods.


Healthy men aged 30 to 60 years

You can take part if:



You may not be able to take part if:


1. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 12. Subjects who are, or are immediate family members of a study site or sponsor employee3. Subjects who have previously been administered IMP in this study4. History of any drug or alcohol abuse in the past 2 years5. 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 admission7. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission8. 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 months9. Subjects with partners who are pregnant or lactating or planning to become pregnant during the study ore within 90 days after study drug administration10. 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 study11. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening/pre-dose12. 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 admission14. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results15. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of <80 mL/min using the Cockcroft-Gault equation16. History of clinically significant cardiovascular, renal, hepatic, pulmonary, gastrointestinal, hematologic, neoplastic, endocrine, immunological, neurological or psychiatric disease or disorder, as judged by the investigator17. 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 excipients20. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active21. Donation or loss of greater than 400 ml of blood within the previous 3 months22. 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 normal (ULN) values at screening or baseline (Day -1): alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl-transpeptidase, direct bilirubin, indirect bilirubin, and total bilirubin. Only abnormal values between up to 1.5 × ULN may be repeated once for confirmation of a return to normal range.25. Any of the following abnormalities on 12-lead ECG or blood pressure at screening, confirmed by repeat:25.1. PR (PR interval) ≥220 msec25.2. QRS (QRS complex) ≥120 msec25.3. QT (QT interval) ≥ 500 msec25.4. QTcF (Fridericia’s corrected QT interval) ≥450 msec25.5. Sitting (for at least 5 min) systolic blood pressure >140 mmHg25.6. Sitting (for at least 5 min) diastolic blood pressure >90 mmHg26. Any of the following abnormal laboratory test values at screening or baseline (Day -1):26.1. Haemoglobin <12.8 g/dl26.2. Haematocrit <37%26.3. Total white blood cell <3.0 × 10e9/l26.4. Platelet count <100 × 10e9/l26.5. Neutrophils <1.4 × 10e9/L and < 1.0 × 10e9/l for black/African-American subjects26.6. Creatine kinase >3 × ULN27. Clinically significant history of depression or suicidal thoughts within the previous 12 months prior to screening28. Failure to satisfy the investigator of fitness to participate for any other reason


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Quotient Sciences, Ltd.
    Mere Way Ruddington Fields Ruddington
    Nottingham
    NG11 6JS

There will be no benefit to the participants. The main risks will be the frequent collection of blood samples and exposure to radioactivity from the study drug. Blood sampling is a standard procedure which is unlikely to cause subjects any problems but can sometimes cause discomfort. Collecting a blood sample from a vein may cause pain, swelling, bruising, light headedness, fainting, and very rarely, clot formation, nerve damage and/or infection at the site of the needle stick. [14C]-zavegepant is the test medicine in this study and is radioactive. The radiation is used to trace where the test medicine (and its breakdown products) is in the participant's body. Participants will be exposed to a small amount of radiation that they wouldn’t be exposed to if they didn’t participate in the study. The amount of radiation that subjects would be exposed to from the test medicine is slightly more than two abdominal x-rays, for example, and less than annual background radiation exposure.

Dr Nand Singh
+44 (0)1159749000
Nand.Singh@quotientsciences.com


Dr Nand Singh
+44 (0)1159749000
Nand.Singh@quotientsciences.com


Dr Nand Singh
+44 (0)1159749000
Nand.Singh@quotientsciences.com



The study is sponsored by Biohaven Pharmaceuticals (United States) and funded by Biohaven Pharmaceuticals, Inc..



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Read full details for Trial ID: ISRCTN19930942
Last updated 15 July 2022

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