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

NCT ID: NCT06607744

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-10
• Study Completion Date: 2025-03-25

Brief Summary

The goal of this clinical study is to obtain the bioavailability of the test patch of a generic formulation of Selegiline TDS 6mg/24 hours by Corium Innovations against the comparator (EMSAM), and the systemic and local safety and tolerability will be also observed and evaluated.

Detailed Description

This is a pilot, single-dose, single-centre, open-label, randomised, 2-way crossover study (2 treatments, 2 periods and 2 sequences) of a generic test formulation of Selegiline TDS 6 mg/24 hours with the comparator EMSAM® TDS 6 mg/24 hours, with at least 14 days washout period, recruiting around 12 healthy male and female subjects.

For each study period, subjects will be admitted and confined in the clinical study site the night before the study day from at least 10 hours before dosing and they will be discharged once all PK, safety and tolerability are completed at 36 hours after dosing. Subjects will be required to return for subsequent PK, safety and tolerability at 48-, 72- and 96-hours post-dosing. The clinic will follow up by telephone 7 ± 3 days after completion of the study.

Pharmacokinetic Blood Sampling:

PK blood samples will be collected before dosing and at 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 30, 36, 48, 72, 96 hours after dosing.

Pharmacokinetics:

PK parameters include AUC0-t, AUC0-∞, Cmax, tmax, t½, tlag (if applicable), λz, and Mean residence time (MRT) will be evaluated for Selegiline.

Safety:

Safety will be assessed on all subjects who participate in the study from the beginning to the end. Adverse events (AEs), abnormal vital signs, abnormal ECG results, abnormal physical examination findings and abnormal clinical laboratory test results will be reviewed on a subject-to-subject basis.

Conditions

MDD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group1: Selegiline TDS of test formulation (6mg/24 hours)

Group1: 1 x Selegiline TDS 6 mg/24 hours manufactured by Corium Innovations, Inc., worn over 24 hours on cleaned upper left or right arm approximately from 8 AM following the randomisation schedule.

Pharmacokinetic profiles of Selegiline TDS and EMSAM

Intervention Type: DRUG

Selegiline concentrations will be measured in blood plasma using a validated liquid chromatography tandem mass spectrometry method from Selegiline TDS (test formulation 6mg/24 hours) and EMSAM (6mg/24 hours). The analytical laboratory will be blinded as to samples which are the test and reference products.

Group2: EMSAM TDS (6 mg/24 hours)

1 x EMSAM® TDS 6 mg/24 hours manufactured by Somerset Pharmaceuticals, Inc., worn over 24 hours on cleaned upper left or right arm approximately from 8 AM following the randomisation schedule.

Pharmacokinetic profiles of Selegiline TDS and EMSAM

Intervention Type: DRUG

Selegiline concentrations will be measured in blood plasma using a validated liquid chromatography tandem mass spectrometry method from Selegiline TDS (test formulation 6mg/24 hours) and EMSAM (6mg/24 hours). The analytical laboratory will be blinded as to samples which are the test and reference products.

Interventions

Pharmacokinetic profiles of Selegiline TDS and EMSAM

Selegiline concentrations will be measured in blood plasma using a validated liquid chromatography tandem mass spectrometry method from Selegiline TDS (test formulation 6mg/24 hours) and EMSAM (6mg/24 hours). The analytical laboratory will be blinded as to samples which are the test and reference products.

Intervention Type: DRUG

Other Intervention Names

Systemic and local tolerability

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Corium Innovations, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Ampang

Pandan Mewah, Ampang, Malaysia

Site Status: RECRUITING

Sarawak General Hospital

Samoran, Sarawak, Malaysia

Site Status: ACTIVE_NOT_RECRUITING

Countries

Malaysia

Central Contacts

David Xu, Director of Clinical Department, MD, PhD

Role: CONTACT

David.Xu@coriumintl.com

1-616-8982176

Related Links

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021336

FDA Approved Drugs

Other Identifiers

SE101

Identifier Type: -

Identifier Source: org_study_id