GL 3507-0067 Part B

 

Stipend and Dates

Up to $7,860.

Note: All dates & times are tentative and may change	Cohort B
Period 1 - Day -1 Admit	May 15, 2023
Period 1 - Day 4 Discharge	May 19, 2023
Period 2 - Day -1 Admit	May 22, 2023
Period 2 Day 7 Discharge	May 29, 2023
Day 18 End of Study Visit	Jun 10, 2023

 

Click here to make an appointment GL 3507-0067 Part B

Or call 210-225-5437 for more information

 

Study Criteria

Healthy Males and Females (Child bearing and non-child bearing allowed)

Age:  18-55

BMI:  18-30 – Must weigh at least 110 pounds

 

Study Information

Indication: The investigational drug is being developed as a possible treatment of sickle cell disease.

Route of Administration: Oral

Washout from previous study: Participation in a clinical study and received treatment within 30 days or 5 half-lives, whichever is longer, prior to screening.

Females of childbearing potential must agree to use a highly effective method of contraception or practice abstinence from 2 weeks prior to study start through 30 days after the last dose of study drug. A highly effective method of contraception is defined as one that results in a low documented failure rate when used consistently and correctly such as: condom plus use of an IUD; intrauterine system or hormonal method of contraception (oral, injected, implanted, or transdermal) for their female partner; or sexual abstinence. 

Males must be surgically sterilized, or agree to practice true abstinence, or use acceptable contraception if sexually active with a female partner of childbearing potential, throughout the study, and for at least 30 days after the last dose of study drug.

Males must agree to not donate sperm during the study and for 30 days following last dose of 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.