ICON Early Phase Services is conducting a research study for healthy non-smoking males and females ages 18-55. The purpose of this study is to test the effect of an investigational drug on some of the electrical properties of the heart. The study drug being developed to treat mood disorders and will be given orally.

Click here to make an appointment for SA 3112-0130

Or call 210-225-5437 for more information

Vital signs, electrocardiogram (ECG; recording of the heart’s activity), Holter monitor (portable device that measures and records your heart activity (ECG) continuously), physical examinations, drug, tobacco and alcohol testing will be performed. Blood and urine samples will also be obtained during this study. 

Participants will complete:

  • Screening visit
  • 10 Consecutive overnight stays in the clinical research unit
  • 1 Follow up phone call (Day 17)

To determine if you fully qualify, it will be necessary to obtain blood samples after an 8- hour fast.  You have the option of fasting for the screening appointment, or, you may return later.   For more information, see below.

Eligible participants may be compensated up to $5,250 for time and travel. Partial stipend payment available.

STUDY DATES

*all dates and times are tentative and may change; ** NOTE: Cohort 1B will be filled before patients are placed in Cohort 1C. Cohort 1B Cohort 1C
Admit - Day -1 Aug 08, 2021 Sun Aug 25, 2021 Wed
(Holter monitoring Day1-3 & Day 7-10)    
Discharge - Day 10 Aug 18 Wed Sep 04 Sat
Follow-up Phone Call - Day 17 Aug 25 Wed Sep 11 Sat

 

If you are able to answer “YES” to the following statements, you may qualify for this study.

  • I am a healthy non-smoking male or female, meaning no significant medical conditions
  • I am between 18 and 55 years old
  • My BMI is between 18.0 and 33.0 kg/m2   and I weigh at least 110 pounds
  • I have not received treatment with an investigational drug, biologic or device in a clinical trial within 30 days prior to screening for this study  
  • If Female, I am non-childbearing and meet one of the following criteria- postmenopausal or surgically sterile (ovaries and uterus removed)
  • If Female, I am childbearing and agree to use one of the following while participating in the study and for 30 days after the last dose of study drug –
    • Combined (estrogen and progestogen containing) oral, intravaginal, or transdermal hormonal contraception associated with inhibition of ovulation
    • Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation
    • Intrauterine device
    • Intrauterine hormone-releasing system
    • Bilateral tubal ligation or bilateral tubal occlusion (performed at least 3 months prior to screening)
    • Vasectomized partner (performed at least 3 months prior to screening)
    • Sexual abstinence (no sexual intercourse)
  • If Male, I agree to refrain from sperm donation and use an effective method of contraception for the duration of the study and for 5 days after last dose of study drug such as
    • Male condom with spermicide used together with highly effective female contraceptive method (see list above)
    • Sexual abstinence (no sexual intercourse)
    • Vasectomy
  • I have suitable veins for multiple blood samples
  • I am able to communicate effectively in English with the study personnel

Screening Reminders -

  • 8 hours fasting is required for lab work (only water is allowed)
  • If taking medications, bring them to your screening appointment.
  • Bring a valid, non-expired photo ID with you when you attend your screening visit.  We accept a government issued identification card such as a driver's license, state issued ID card, military ID 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
SA 3112-0130
Name
Healthy Adults
Details
NEW APPOINTMENTS AVAILABLE!
Gender
Male or Female
Payment amount
Up to $5,250
Age
18 - 55
Smoking
Non-smokers