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.
ICON Early Phase Services is conducting a research study for healthy non-smoking Adults ages 18-55.
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:
•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.
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
Name of Clinical Site
8307 Gault Lane, San Antonio, TX, USA