BR 4584-0013 Part A SAD

ICON Early Phase Services is conducting a research study for healthy non-smoking Adults ages 18-55. The purpose of this study is to evaluate the safety and effect of an investigational drug to treat HIV. Different doses of the study drug in oral liquid form are being evaluated in this study. You will be given the study drug orally 1 time.

CLICK HERE to make an appointment for BR 4584-0013

Or call 210-225-5437 for more information

Vital signs, ECGs, physical examinations, drug, alcohol and tobacco testing will be performed. Blood, nasopharyngeal and urine samples will also be obtained during this study. 

Participants will complete:

  • Screening visit
  • 14 Consecutive overnights
  • 1 Follow up Visit (Day 28)

The length of the study from the first admit to end of study is approximately 28 days.

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.

Qualified participants may be compensated up to $7,735 for study completion.

Study Dates

Note: All dates and times are tentative and may change.
 
Cohort 2
Admit Jun 07, 2021 Mon
Discharge Jun 21 Mon
End of Study Visit July 04

 

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 18.5 and 32.0 kg/m2   and my weight is equal to or greater than 110 pounds (for men) and is equal to or greater than 99 pounds (for females).
  • My GFR is greater than 80 mL/min 
  • I have not participated in a clinical trial and received an investigational drug within 30 days (or 5 half-lives) prior to dosing
  • If Female, I meet one of the following: 
  • Postmenopausal (no menses for 12 months)
  • Surgically sterile ( hysterectomy, documented tubal ligation, documented tubal occlusion  or documented bilateral oophorectomy)
  • Abstinence- who have established, long-term lifestyle of sexual abstinence, or only same sex partners, require no other means of birth control.
  • Vasectomy for male partners (of female subjects who are able to get pregnant). Confirmed with documentation of azoospermia (absence of sperm in semen)
  • Child bearing and currently use one of the following (and agree to comply from the 1st dose of study medication until 30 days after last dose of study medication ) with a male condom–
  1. Contraceptive subdermal implant that meets the effectiveness criteria including a <1% rate of failure per year, as stated in the product label.
  2. Oral contraceptive, either combined or progestogen alone or injectable progestogen.
  3. Contraceptive vaginal ring
  4. Contraceptive patches.  Intrauterine device or intrauterine system that meets the effectiveness criteria including a <1% rate of failure per year, as stated in the product label
  • If Male, I agree to refrain from sperm donation and use one of the following and agree to comply from the 1st dose of study medication until 30 days after last dose of study medication:
    • Vasectomy with documentation
    • Male condom plus Contraceptive subdermal implant that meets the effectiveness criteria including a <1% rate of failure per year, as stated in the product label. Oral contraceptive, either combined or progestogen alone or Injectable progestogen. Contraceptive vaginal ring Contraceptive patches.
  • 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.
Name
BR 4584-0013
Details
Healthy Adults - Not currently screening, pending labs.
Gender
Male or Female
Payment amount
up to $7,735
Age
18 - 55