Clinical trial NCT06607744: Determine the Bioavailability of Selegiline TDS 6mg/24 Hours vs EMSAM in Healthy Subjects
Official title: The Comparative Pilot Bioavailability Study of a Generic Test Formulation of Selegiline TDS 6 mg/24 Hours Against the Comparator EMSAM® 6 mg/24 Hours in Healthy Adult Subjects
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: MDD
Keywords: Selegiline TDS
Bioavailability
Pharmacokinetic
Lead sponsor: Corium Innovations, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Local subjects participate in the Hospital Ampang, Malaysia

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.

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 \&lt; 50 bpm, or asymptomatic heart rate \&lt; 45 bpm; and sinus tachycardia defined as heart rate \&gt; 100 bpm.
5. Clinically significant ECG abnormalities (PQ interval \&gt; 0.2 s, Duration of the QRS complex \&gt; 0.1 s, AV block).
6. QTc \&gt; 450 ms for male and \&gt; 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 \&lt; 12.0 g/dL for male and \&lt; 11.0 g/dL for female at screening.
13. Total bilirubin \&gt; 1.25 x upper limit of normal, ALT/AST \&gt; 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.

Primary outcomes:
measure: Plasma Pharmacokinetic-AUC 0-t
timeFrame: 22 days
measure: Plasma Pharmacokinetic-AUC 0-∞
timeFrame: 22 days
measure: Plasma Pharmacokinetic-Cmax
timeFrame: 22 days
measure: Plasma Pharmacokinetic-Tmax
timeFrame: 22 days
measure: Plasma Pharmacokinetic-T1/2
timeFrame: 22 days
measure: Plasma Pharmacokinetic-Tlag
timeFrame: 22 days
measure: Plasma Pharmacokinetic-MTR
timeFrame: 22 days
measure: Plasma Pharmacokinetic-λz (Lambda z)
timeFrame: 22 days
Secondary outcomes:
measure: Safety-Topic Skin Irritation
timeFrame: 22 days
Other outcomes:
Locations:
city: Pandan Mewah
country: Malaysia
facility: Hospital Ampang
state: Ampang
city: Samoran
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
Study officials:
References: