Migraine Nervous System Diseases
Conditions
Interventions
This Phase I, open-label, single-center, single-period, non-randomized study includes healthy male volunteers. After an overnight fast of 8 hours, volunteers are dosed on the morning of Day 1 with a s
Sponsors
Biohaven Pharmaceuticals (United States)
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rates and routes of elimination of the test medicine from the body, and the ways in which the body processes the test medicine will be assessed by taking whole blood, plasma, urine, and feces for liquid scintillation counting to measure the amount of radioactivity, and to identify breakdown products of the test medicine by liquid chromatography with radio detection and high-resolution mass spectrometry, between Days 1 and Day 11. Participants' stay may be extended an additional 2 days and they may need to continue collections of urine and faeces for a few days at home after they have left the ward. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The intravenous pharmacokinetics of the test medicine in plasma, feces, and urine after a single dose will be assessed by taking blood samples and urine samples for liquid chromatography with tandem mass spectrometry (LC-MS/MS assay) of the test medicine between Days 1 and Day 11 2. Adverse events (to assess tolerability of the test medicine) will be collected by asking volunteers how they are feeling from the start of the trial until follow up 3. Other safety measures (including vital signs, ECGs and laboratory safety tests) will be assessed by standard phase 1 unit monitoring at screening, from Day-1 to discharge from the ward | — |
Countries
England, United Kingdom
Contacts
Public ContactNand Singh
Outcome results
None listed