Depression Mental and Behavioural Disorders
Conditions
Interventions
Current interventions as of 21/04/2023:
In Part 1 volunteers received escitalopram once daily until Day 28 and received two doses of 5 HTP/carbidopa GR tablet or placebo (12 hours apart) on a single d
Sponsors
Evecxia Therapeutics Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 21/04/2023: 1. Healthy males or non-pregnant, non-lactating healthy females 2. Aged 18 to 55 years old for Part 1 and aged 25 to 55 years old for Part 2 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. Weight =50 kg at screening 5. Must be willing and able to communicate and participate in the whole study 6. Must provide written informed consent 7. Must agree to adhere to the contraception requirements defined in the clinical protocol Previous participant inclusion criteria: Healthy volunteer
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 21/04/2023: 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 received 5-HTP/Carbidopa in study EVX101-101/QSC201140 4. Subjects who have previously been administered IMP (5-HTP/carbidopa GR tablet or placebo) in this study. Subjects who have taken part in Part 1 are not permitted to take part in Part 2 5. Evidence of current SARS-CoV-2 infection within 4 weeks of Day 1 6. History of any drug or alcohol abuse in the past 2 years 7. Regular alcohol consumption in males >21 units per week and females >14 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) 8. A confirmed positive alcohol breath test at screening or Day 1 9. Results at screening indicative of chronic excess alcohol intake 10. 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 Day 1 11. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months 12. Females who are pregnant or lactating (all female subjects must have a negative highly sensitive pregnancy test) 13. Male subjects with pregnant or lactating partners 14. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening 15. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are allowed 16. Platelet count, serum sodium, potassium or magnesium below the lower limit of the reference range at screening. For Part 2 only, haemoglobin below the lower limit of the reference range at screening 17. Clinically significant findings on ECG or vital signs as assessed by the investigator at screening or Day 1 18. QTcF >450 msec at screening or Day 1 or known QT interval prolongation or congenital long QT syndrome 19. Confirmed positive drugs of abuse test result 20. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results 21. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or neurological disorder, as judged by the investigator 22. History of any psychiatric disease requiring treatment in the last 5 years 23. Known history of glaucoma or raised intraocular pressure 24. Presence or history of any GI disease including peptic ulceration, GI bleeding, ulcerative colitis, Crohn’s Disease 25. Subjects with a history of cholecystectomy or gall stones 26. Subjects unwilling to eat at least 90% of the pre-dose meals 27. Subject answers "yes" to "Suicidal Ideation" Items 1 or 2 on the C-SSRS (lifetime) at screening or Day 1 28. Serious adverse reaction or serious hypersensitivity to any drug (including serotonergic drugs such as anti-depressants and migraine medication) or the formulation excipients 29. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active 30. Donation of blood or plasma within the previous 3 months or loss of g
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 21/04/2023: Part 1: Pharmacokinetic (PK) parameters following dosing of 5-HTP/carbidopa GR tablet as single ascending doses split 12 hours apart were measured using analysis of plasma samples taken from pre dose to Day 28. PK parameters include but are not limited to: Tmax, Cmax, AUC(0-12), AUC(0 last), AUC(0 inf) and T1/2 Safety and tolerability was assessed throughout the study, from dosing to final follow up calls (Day 1 to Day 42). Safety endpoints will be measured via incidence of AEs, physical examinations and change from baseline for vital signs, ECGs, C-SSRS, Hunter serotonin toxicity criteria, and laboratory safety tests Part 2: PK parameters following dosing of 5-HTP/carbidopa GR tablet as multiple ascending doses split twice daily were measured using analysis of plasma samples taken from pre dose to Day 61. PK parameters include but are not limited to: Tmax, Cmax, AUC(0-12) and T1/2. Safety and tolerability was assessed throughout the study, from dosing to final follow up visits (Day 1 to Day 61). Safety endpoints will be measured via incidence of AEs, physical examinations and change from baseline for vital signs, ECGs, C-SSRS, Hunter serotonin toxicity criteria, and laboratory safety tests. Previous primary outcome measure: The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record when the results are published, which will be within 30 months after the trial has ended. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 21/04/2023: Part 1: PK parameters for 5-HTP following single ascending doses of carbidopa were measured using analysis of plasma samples taken from pre-dose to Day 28. PK parameters include but are not limited to: Cmax, AUC(0 12), AUC(0-last) and AUC(0-inf). Changes from baseline in serum cortisol levels were measured using analysis of plasma samples taken from pre-dose to Day 28. Part 2: PK parameters for 5-HTP following multiple ascending doses of carbidopa were measured using analysis of plasma samples taken from pre-dose to Day 61. PK parameters include but are not limited to: Cmax and AUC(0-12). Changes from baseline in serum cortisol levels were measured using analysis of plasma samples taken from pre-dose to Day 61. Previous secondary outcome measure: The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record when the results are published, which will be within 30 months after the trial has ended. | — |
Countries
England, United Kingdom
Contacts
Public ContactJacob Jacobson
Outcome results
None listed