Stipend and Dates
Up to $5,200. (Multiple payments)
|All dates and times are tentative and may change.You cannot pick which cohort you go into. The first cohort is filled and then patient are placed in the next cohort.||Cohort 2a||Cohort 2b|
|Day -1 Admit (Holter monitor starts Day 1 for 25 hours. No electronics including cell phone, computer, TV, etc. )||Aug 25, 2022 Thurs||Aug 29, 2022 Mon|
|Day 6 Discharge||Aug 31, 2022 Wed||Sep 04, 2022 Sun|
|Day 10 Phone Call||Sep 04 Sun||Sep 08 Thurs|
|Day 15 End of study Visit||Sep 09 Fri||Sep 13 Tue|
|Day 31 Follow up Phone Call||Sep 25 Sun||Sep 29 Thurs|
Or call 210-225-5437 for more information
Healthy non-smoking Males and Females (non-child bearing) that have been fully COVID-19 vaccinated (valid documentation required)
BMI and Weight: 18 to 30 kg/m2 and weigh at least 110 pounds
GFR : greater than 80
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.
- 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.
- NO 21944-21944X
- Healthy Males and Non-childbearing Females Fully vaccinated for COVID-19
- Valid documentation required of COVID-19 vaccination at screening.
- Male or Female
- Payment amount
- Up to $5,200
- 18 - 55