Determine the Bioavailability of Selegiline TDS 6mg/24 Hours vs EMSAM in Healthy Subjects

Launched by CORIUM INNOVATIONS, INC. · Sep 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new version of a medication called Selegiline, which is delivered through a skin patch. The goal is to see how well this generic patch works compared to an existing patch called EMSAM in healthy individuals. The study will also look at how safe the patch is for participants and whether they experience any side effects.

To be eligible for this trial, participants must be between 18 and 55 years old, in good health, and not using certain medications or substances that could interfere with the study. They will need to wear the patch and follow specific instructions throughout the trial. Participants can expect regular check-ins to monitor their health and safety during the study. It's important to know that individuals with certain medical conditions or those who have recently taken specific medications may not qualify for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject age between 18 to 55 years old with adequate contraception but without taking oral contraceptives.
• • 2. Subject body weight ≤ 120 kg, with a BMI within 18-30 kg/m².
• • 3. Subject is able to complete the clinical study including the follow-up.
• • 4. Subject is capable of providing written informed consent.
• • 5. Subjects are able and willing to follow the requirements of the study and wearing patches.
• Exclusion Criteria:
• • 1. Breastfeeding female.
• • 2. Pregnancy test positive female.
• • 3. At rest systolic blood pressure outside 90-140 mmHg or diastolic blood pressure outside 50- 90 mmHg or orthostatic hypotension.
• • 4. At rest sinus bradycardia defined as symptomatic heart rate \< 50 bpm, or asymptomatic heart rate \< 45 bpm; and sinus tachycardia defined as heart rate \> 100 bpm.
• • 5. Clinically significant ECG abnormalities (PQ interval \> 0.2 s, Duration of the QRS complex \> 0.1 s, AV block).
• • 6. QTc \> 450 ms for male and \> 460 ms for female.
• • 7. A history of allergies, or any significant adverse reactions, to any medications, unless the clinician considers that they are not clinically significant.
• • 8. Clinically significant medical history of eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, genitourinary, neurological, haematopoietic, lymphatic, endocrine, metabolic, dermatological, musculoskeletal, psychological, family history or surgical history.
• • 9. Family history of sudden cardiac death or pheochromocytoma.
• • 10. Clinically significant physical examination finding or psychiatric unstable conditions or psychiatric illness requiring treatment.
• • 11. Clinically significant laboratory abnormalities.
• • 12. Haemoglobin \< 12.0 g/dL for male and \< 11.0 g/dL for female at screening.
• • 13. Total bilirubin \> 1.25 x upper limit of normal, ALT/AST \> 1.5 x upper limit of normal.
• • 14. Hepatitis B, Hepatitis C or HIV positive.
• • 15. Urine DOA test positive.
• • 16. Breath alcohol test positive.
• • 17. Any smoker with tobacco or electronic tobacco products.
• • 18. A history of drug or substance abuse, including alcohol (≥ 14 units per week) within 6 months before consent taking (1 unit of alcohol equals approximately ½ pint \[285 mL\] of beer, 1 glass \[125 mL\] of wine, or 1 shot \[25 mL\] of spirit).
• • 19. Taking selective serotonin reuptake inhibitors (SSRI), serotonin and norepinephrine reuptake inhibitors (SNRI) or cough or cold medicine (e.g., dextromethorphan, pseudoephedrine) or using carbamazepine or oxcarbazepine, or using meperidine and analgesic agents such as tramadol, methadone, and propoxyphene, or using sympathomimetic agents.
• • 20. Unable to refrain from taking any medications (including herbal remedies) within 7 days before dosing, with the exception of birth control medications and other medications deemed acceptable by the Investigator.
• • 21. Clinically significant illness or injury or hospitalisation for any reason within 28 days before consent taking.