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 tolerability of multiple doses of an investigational drug to treat HIV. Different oral formulations of the study drug designed to deliver drug over a period of time will be evaluated in this study. In cohort 9, you will be given the FDA approved immediate release drug Edurant (orally with food) daily for 11 days.
Clinical trial study BR 4584-0010 MAD Cohort 9
Participants will complete:
•12 Back-to-back overnights
The length of the study from the first admit to end of study is approximately 13 days.
Vital signs, ECGs, physical examinations, drug and tobacco testing will be performed. Blood and urine samples will also be obtained during this study.
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.
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 29.9 kg/m2 and my weight is more than 110 pounds (for men) and more than 99 pounds (for females).
•I have not participated in a clinical trial and received an investigational drug within 30 days or 5 half-lives( the time it takes for amount of the drug in your body to be reduced by half) of an investigational product 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)
-Child bearing and currently use one of the following with a male condom–
-Hormonal contraceptives (oral, injectable, implant, vaginal ring, patches)
-IUD (with or without hormonal releasing system)
-Long term lifestyle of sexual abstinence or only same sex partners
•If Male, I agree to use one of the following during the study and for 1 week following the last dose of study drug:
-Male condom and a highly effective hormonal method of contraception (oral, injectable, implant, vaginal ring, patches)
-Male condom and Intrauterine device
-Male condom and contraceptive vaginal ring or contraceptive patches
-Vasectomy with documentation
•I have suitable veins for multiple blood samples
•I am able to communicate effectively in English with the study personnel
•I have not received a vaccination (including influenza) within the 30 days prior to the planned dose
Name of Clinical Site
8307 Gault Lane, San Antonio, TX, USA