NO 21944-21944x MAD/FE

Stipend and Dates

Up to $10,000. (Multiple payments)

All dates & times are tentative and may change.	MAD Cohort 3
Day -1 Admit - There is holter monitoring during this study. No electronics (cell phones, computers, tv, etc) during those time periods.	Oct 25, 2023
Day 11 Discharge	Nov 05, 2023
Day 15 Phone call	Nov 09
Day 22 Outpatient visit	Nov 16
Day 38 Phone call	Dec 02

 

Click here to make an appointment for NO 21944-21944x MAD/FE

Or call 210-225-5437 for more information

 

Study Criteria

Healthy non-smoking Males and Females (non-childbearing) that have been fully COVID-19 vaccinated (valid documentation required)

Age:  18-55

BMI and Weight:  18 to 30 kg/m2  and weigh at least 110 pounds

GFR :  greater  than 80

 

Study Information

Indication: The investigational drug is being developed as a potential treatment for major resistant depressive disorder.

 Route of Administration: Oral

Washout from previous study: Use of other investigational drugs within 30 days before screening

 

Females in the following categories are considered non-childbearing:

• Documented total hysterectomy (removal of uterus and ovaries), bilateral tubal ligation or bilateral oophorectomy confirmed by hormone level assessment (removal of both ovaries).
• Menopause more than 12 months prior to study entry (stopped having monthly menstrual periods more than 12 months ago).

 

Acceptable Birth Control for Males: Males must agree to use condoms during intercourse while taking drug and until end of study visit.

Male subjects must agree not to donate sperm or father a child while taking drug and until end of study visit.   

 

Study Reminders

• 10 hours fasting is required for lab work (only water is allowed)
• If taking medications, bring them to your screening appointment (including prescription, over the counter, herbal supplements and vitamins)
• Bring a valid, non-expired photo ID with you when you attend your screening visit.  We accept a valid government issued identification card such as a driver's license, state issued ID card or passport.  You will be required to show this same photo ID at all study visits
• Arrive 30 minutes before your appointment to complete paper work.