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ICON Early Phase Service Clinical Trial Study for Lactating Females in San Antonio, TX
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.
Phase: I
Health Conditions: Healthy Volunteers Studies
Reference #: NO 0009-0537
Sponsored by: ICON Early Phase Services
Stipend: $6,500
Length of Study: 7 Weeks
Additional Qualifying Information / Important Inclusions or Exclusions:
Gender: Female
Age: 18 – 100
In-patient or stay overnight at the research center? Yes
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.
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
Vital signs, ECGs, physical examinations, drug and alcohol testing will be performed. Blood and urine samples will also be obtained during this study.
ICON Early Phase Services
8307 Gault Ln, San Antonio, TX 78209, USA
ICON Early Phase Service
Study Scavenger Provides the Below Helpful Information
In-Patient/Out-Patient Explained
There are two main reasons clinical research trials are done in an isolated inpatient setting where the patient stays overnight at a research clinic: 1) To protect the study participant: Some study agents, usually challenge products, can make some people quite sick. Study participants stay on the inpatient unit to receive 24 hour nursing care during these types of studies. Participants stay on the isolation unit until their laboratory test show they are no longer shedding the infectious agent. 2) To protect the public: An infectious study agent that is given to a study participant may be harmful to the general public’s health. Therefore, study participants stay on the inpatient unit until the possibility of giving the infection to someone else has passed.
An outpatient vaccine trial is a study that does not require an overnight stay in the hospital or research clinic. Participants are given an investigational agent and have scheduled clinic visits to monitor how well they tolerate the investigational agent. Most studies require the clinic staff to follow up with subjects on a daily, weekly or monthly schedule. Clinic visits can range from 2 to 4 hours, depending on the study and the type of visit. – National Institute of Health
Screening Visit
Screening Visit: Potential candidates for a Study will participate in an initial screening visit to determine if they are appropriate for the Study. When you first attend the screening visit for phases I-III, the study is explained in detail and you can ask any questions. If you decide to participate, the study nurse will review the informed consent form with you and ask for your signature and permission to proceed with the screening evaluations. – – National Institute of Health
Washout Period Explained
A period during a clinical trial when the trial subjects receive no active medication. The wash-out period is typically used to generate patient baseline data. Every clinic has a washout period during which you are not allowed to do a study at the same clinic or any other clinic.
The minimum period is 30 days since last dose, however some washouts go based on last study procedure (such as out patient visits or how much blood you gave during the study). The washout period may vary from study to study depending on the half-life of the drug. Certain studies like radio-labeled drugs will have a 1 year washout before you can do another radio-labeled drug. In addition to the clinic’s washout policy, the sponsor may impose a longer washout period. Some studies will have a longer washout before you can sign up.
In general, you can sign up and screen for another study during the washout period as long as the check in date is at least 30 days after your last dose in the previous study. However, depending on how fast your body recovers from a study, you may want to wait the full period to avoid problems with screening.
People who screen too soon after a study typically have lower red blood cell, hemoglobin, hematocritand iron. If these levels are too low, you could get banned from participating in studies because having low levels is unhealthy and unsafe for participating in a study.
Be forewarned that many clinic participate in the VCT (Verified Clinical Trials) program which tracks when you do a study to ensure the next study meets washout periods. I do not mention these clinics because it shouldn’t matter. You know the rules and if you break them, the consequences can be dire like being banned from a clinic. Sometimes the only way to drive this message home is to allow people to find out the hard way. – – National Institute of Health