NO 0009-0537

Study for Lactating Females

ICON Early Phase Services is conducting a research study for healthy lactating females ages 18 and older. The purpose of this study is to determine whether an FDA approved drug (used to treat adults with type 2 diabetes) is present in breastmilk of lactating women, and to estimate the amount of study drug that could reach the nursing infant via breastmilk. This will provide information to women and health care providers when selecting appropriate treatment for type 2 diabetes during lactation. If you qualify for the study, you will receive the study drug once daily for 10 days in tablet form for oral (by mouth) intake.

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Or call 210-225-5437 for more information 

 

Vital signs, ECGs, physical examinations, drug and alcohol testing will be performed. Blood and urine samples will also be obtained during this study. 

Participants will complete:

• Screening visit
• 3 Non-Consecutive overnights
• 8 home nurse visits or onsite visits
• 2 phone calls
• 1 follow up visit

To determine if you fully qualify, it will be necessary to obtain blood samples after a 6- hour fast.  You have the option of fasting for the screening appointment, or, you may return later.   For more information, see below.

 

Qualified participants may be compensated up to $6,500. for time and travel for completion of this study.

 

*THESE ARE EXAMPLE DATES. Your actual dates will be individualized.	Group 6
Visit 1 - Screening
Day -1 - Admit to clinic 11:00am	May 15, 2023
Day 1 - in clinic	May 16
Day 2 at home dose	May 17
Day 3 at home dose	May 18
Day 4 at home dose	May 19
Day 5 at home dose	May 20
Day 6 at home dose	May 21
Day 7 at home dose	May 22
Day 8 at home	May 23
Day 9 at home dose in morning	May 24
Day 9 admit to clinic in afternoon	May 24
Day 10 in clinic	May 25
Day 11 in clinic/ discharge	May 26
Day 25 phone call	Jun 09
Day 39 phone call	Jun 23
Day 47 end of study visit	Jul 01

 

If you are able to answer “YES” to the following statements, you may qualify for this study.

 

• I am a healthy female 18 years or older, meaning no significant medical conditions
• I am currently breastfeeding my baby and produce sufficient milk to fulfil the study requirements, as judged by the investigator.  
• I have given birth at least 2 months prior to screening
• My BMI is between 20 and 35 kg/m2   
• I am willing to refrain from breast feeding and use a breast pump to collect the breast milk during the study
• I have not participated in a clinical trial within 60 days (or 5 half-lives) prior to screening
• I agree to use an effective method of contraception
• I have suitable veins for multiple blood samples
• I am able to communicate effectively in English with the study personnel

Screening Reminders -

• 6 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.