Stipend and Dates

Up to $15,300. (multiple payments)

  Cohort 3
Admit Jun 14, 2022 Tue
Discharge 1 or 2 or 3 - based on dosing level Jul 07 or Jul 08 or Jul 09
Follow Up Visit Jul 31, 2022 Sun

 

Click here to make an appointment for EM 6179-0001 Cohort 3

Or call 210-225-5437 for more information

Study Criteria

Healthy Males and Females(non-childbearing)

Age:  18-54

BMI and Weight:  18.6 to 29.9 kg/m2    Males at least 110 pounds & Females at least 100 pounds

GFR greater than 90mL/min

Study Information

Indication: The investigational drug is being developed as a possible treatment for adults with Childhood-onset fluency disorder (stuttering/stammering) and in pediatric Tourette disorder.

Route of Administration: Oral

Washout from previous study: Participation in an investigational drug product or medical device within 30 days before dosing or administration of a biological product within 90 days prior to first dosing.

Males who have not been vasectomized for at least 6 months prior to screening and are sexually active with female partner of childbearing potential must agree to use a double barrier method of contraception during the study and agree to continue the use of male contraception for at least 90 days after the last does of study drug.

Male subjects with a pregnant partner must agree to use a condom from the first study drug administration until at least 90 days after the last study drug administration.

Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.

Females must not be able to have children (non-childbearing):

  •  Hysterectomy with bilateral oophorectomy (removal of uterus and both ovaries), bilateral tubal ligation, bilateral oophorectomy (removal of both ovaries) at least 6 months prior to drug administration
  • Menopause more than one year prior to study entry (stopped having monthly menstrual periods more than one year ago) and confirmed at screening by a hormone test.

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.
Reference
EM 6179-0001 Cohort 3
Name
Healthy Adults
Gender
Male or Female
Payment amount
Up to $15,300
Age
18 - 54
Smoking
Non-smokers