Stipend and Dates

Up to $35,125.00 for study related time and travel (multiple payments)

All dates and times are tentative and may change. Cohort 6
Day -1 Admit Feb 20, 2023
Day 43 Discharge Apr 04, 2023
Day 45 Outpatient visit Apr 06
Day 49 Outpatient visit Apr 10
Day 55 Outpatient visit Apr 16
Day 63 Outpatient visit Apr 24
Day 71 Outpatient visit May 02
Day 79 Outpatient visit May 10
Day 87 Outpatient visit May 18
Day 95 Outpatient visit May 26
Day 105 Final visit Jun 05

 

Click here to make an appointment for GI 22630-22630x MAD

Or call 210-225-5437 for more information

 

Study Criteria

Healthy Non-Smoking Females

Age:  18-45

BMI:  18 to 32 kg/m2

Adequate kidney function (GFR): greater than 90 mL/min

 

Study Information

Indication: The investigational drug is being developed as a treatment for HIV-1 infection.

Route of Administration: Oral

Washout from previous study: Participants must not have been in any other study or received an investigational drug within 30 days prior to study dosing for this study.

Acceptable Birth Control for Females (if Childbearing): Child bearing Females must use a highly effective contraceptive method during the study beginning at the screening visit until final follow up, after the last dose of investigational drug.

Acceptable methods of birth control for use in this study are:

  • Non-hormonal IUD
  • Bilateral tubal occlusion (documents required)
  • Vasectomized partner (documents required)
  • Sexual Abstinence when in line with the preferred and usual lifestyle

Females in the following categories are considered non-childbearing:

  • Documented hysterectomy (removal of uterus), bilateral salpingectomy (removal of both Fallopian tubes) or bilateral oophorectomy (removal of both ovaries)
  • Postmenopausal when younger than 54 years of age with amenorrhea of at least 12 months if FHS level is in the postmenopausal range and not using hormonal contraception or hormone replacement therapy.

 

Unacceptable Birth Control Methods include Hormonal Contraception, periodic abstinence, withdrawal, spermicides only and lactational amenorrhea method. A female condom and a male condom should not be used together.

Females of childbearing potential must also refrain from egg donation and in vitro fertilization during treatment and until final follow up, after the last dose of investigational drug.

 

Study 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 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
GI 22630-22630x MAD
Name
Healthy Females Only
Details
If you dosed or disqualified for the SAD part of this study, you CANNOT screen. Not Currently Screening.
Gender
Male or Female
Payment amount
Up to $35,125
Age
18 - 45
Smoking
Non-smokers