LO 4583-0014

Stipend and Dates

Up to $7,000.

Note: All dates and times are tentative and may change.	Part 1
Day -1 Admit	Jun 05, 2023 Mon
Day 12 Discharge	Jun 17, 2023 Sat
Day 19 Follow-up Phone Call	Jun 24, 2023 Sat

 

Click here to make an appointment LO 4583-0014

Or call 210-225-5437 for more information

 

Study Criteria

Healthy Males & Females (non-childbearing potential)

Non-Smokers

Age:  18-55

BMI:  18.0 to 32.0 kg/m2  

 

Study Information

Indication: The investigational drug is being developed as a possible treatment of cancer.

Route of Administration: Oral

Washout from previous study: Participation in a clinical study and received treatment within 30 days of the first dose of study drug dosing.

Females subjects of nonchildbearing potential, defined as being permanently sterile, with documented history of permanent sterility, if possible. (ie, due to hysterectomy, bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy, or tubal occlusion more than 3 months prior to Day 1) or postmenopausal (defined as at least 12 months post cessation of menses without an alternative medical cause). Postmenopausal status will be confirmed with a screening serum FSH level.

Female subjects are required to refrain from donation of ova from admission until 3 months after the last administration of the study drug.

 

Male subjects, if not surgically sterilized for at least 3 months prior to admission (with documented confirmation of surgical success), must follow 1 of the contraception methods below when engaging in heterosexual intercourse, from admission until 3 months after the last study drug administration.

            a. Male condom with spermicide (requirement applies to male subjects with women of childbearing potential partners, including those who are currently pregnant or lactating), or

            b. A male subject must ensure that their female partner meets 1 of the following criteria:

• i. IUD (hormonal IUD; eg, Mirena). Copper IUDs are acceptable (eg, ParaGard); or
• ii. Established use of oral, implanted, injected, transdermal, intravaginal, or hormonal method of contraception associated with inhibition of ovulation: or
• iii. Nonchildbearing potential, defined as being permanently sterile (ie, due to hysterectomy, bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy, or tubal occlusion more than 3 months prior to Day 1); or
• iv. Postmenopausal status (defined as at least 12 months post cessation of menses without an alternative medical cause) for at least 1 year prior to Day 1.

Male subjects who practice true abstinence because of lifestyle choice are exempt from contraception requirements. For subjects who are exclusively in same sex relationships, contraceptive requirements do not apply.

Periodic abstinence by a female partner (eg, calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception.

Male subjects are required to refrain from donation of sperm from admission until 3 months after the last administration of the study drug.  

     

Study Reminders

• 8 hours fasting is required for lab work (only water is allowed)
• If taking medications, bring them to your screening appointment (including prescription, over the counter, herbal supplements and vitamins)
• Bring a valid, non-expired photo ID with you when you attend your screening visit.  We accept a valid 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.