A study in healthy male volunteers to investigate how the test medicine is taken up, broken down and removed from the body

Phase 1

Completed

• Conditions: Epilepsy; Nervous System Diseases

• Registration Number: ISRCTN21667877
• Lead Sponsor: Supernus Pharmaceuticals (United States)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-12
• Study Completion: 2022-09-14
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

1. Healthy males
2. Aged 30 to 64 years inclusive at the time of signing informed consent
3. Body mass index (BMI) of 18.0 to 32.0 kg/m² as measured at screening
4. Must be willing and able to communicate and participate in the whole study
5. Must have regular bowel movements (ie average stool production of =1 and =3 stools per day)
6. Must provide written informed consent
7. Must agree to adhere to the contraception requirements defined in the clinical protocol

Exclusion Criteria

1. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
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. Evidence of current SARS-CoV-2 infection
5. History of any drug or alcohol abuse in the past 2 years
6. 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)
7. A confirmed positive alcohol breath test at screening or admission
8. Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
9. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
10. Male subjects with pregnant or lactating partners
11. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other 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
12. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
13. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are not allowed.
14. Confirmed positive drugs of abuse test result
15. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
16. Evidence of renal impairment at screening, as indicated by an estimated CLcr of <80 mL/min using the Cockcroft-Gault equation
17. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
18. Resting heart rate <50 bpm at screening
19. History of bladder outflow obstruction such as benign prostatic hyperplasia or any history of acute urinary retention
20. Creatine kinase =1.5 x upper limit of normal
21. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
22. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
23. Donation of blood or plasma within the previous 3 months or loss of greater than 400 ml of blood
24. Subjects who are taking, or have taken, any prescribed or over-the-counter drug, or herbal remedies or vaccines, including the COVID-19 vaccine, (other than up to 4 g of paracetamol per day) in the 14 days before IMP administration. Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a sho

Study & Design

• Study Type: Interventional
• Study Design: Not specified