Healthy males or females needed for a medical drug study located on site in Lexington, Kentucky. You will receive $9,000 for your participation in one of two groups.
The first group will start Jan 15-Jan 26, with two return visits for checkups on Jan 27 and Jan 28.
The second group will start Feb 2 - Feb 13, with two return visits for checkups on Feb 14 and Feb 15.
If interested, leave a message on the Fort Thomas Matters Facebook page (here) or a text the FTM tip-line, 859-379-5706.
Please read the requirements of the study before leaving a message.
You will need to come to the study site for blood tests, a physical exam, and other tests in order to document your health status (Screening Visit) to see if you qualify.
The basic eligibility requirements are: healthy male or female, 18-55 years old, BMI 18-35 [weight in Kg / height in meters squared], non-smoker for at least the last 6 months, no medications (Rx, OTC, herbal etc.), no significant medical conditions or history (including e.g. gout, asthma, high blood pressure, recent infections etc.), willing to use birth control.
If you qualify, there is one in-patient (overnight) Dosing Visit during the study.
During the Dosing Visit a subject will come in at 9AM three days before the first study drug dose (Day -3) after an overnight fast. You will stay in the research clinic for about 12 consecutive nights. During this time you will receive the study drug or placebo (a “dummy” drug) three times a day by IV infusion over a 7 day period. Other procedures will be performed to determine how well the study drug is working and to monitor your health. You will have a 1 in 4 chance of receiving placebo.
A brief summary of the study procedures is:
· On Day -3 (Day 1 in-house) you will be admitted to the research clinic and your eligibility will be confirmed with blood tests and other procedures such as blood pressure, ECG etc.
· On day after admission (Day -2, Day 2 in-house) you will wear a Holter monitor. A Holter monitor is a small box that records your heart rhythm over about 24 hours. The Holter monitor is attached to you by small sticky pads (leads) and you wear it in a pouch around your waist.
· On the Day -1 (Day 3 in-house) you will drink a liquid meal (Ensure Plus) containing a small amount of radioactivity. This allows us to use imaging to track the location of the radioactive marker in your stomach and intestines using an instrument called a Gamma Camera. That is something you will find in the nuclear medicine department of a hospital. During the imaging, you will stand in front of the gamma camera every 5 minutes for about 2.5 hours. This allows us to determine how long it takes for the liquid meal to leave your stomach (gastric emptying). The radioactive marker will not be absorbed into your body (it is passed by you into the toilet).
· On Day -1 (Day 3 in-house) you will also be administered a liquid dose of acetaminophen (Tylenol). Blood samples will be collected through a catheter placed in your arm to determine how much acetaminophen is absorbed into your body. This information will be can be used to help determine gastric emptying in ICU patients since gamma scintigraphy cannot be easily done in that setting.
· On Day 1 (Day 4 in-house) you will start receiving the study drug by intravenous infusion over 30 minutes every 8 hours for 7 days. The study drug will be infused through a catheter placed in your arm. During these 7 days you will have gamma scintigraphy done 3 more times, receive acetaminophen 2 more times, wear a Holter monitor one more time, have blood samples taken, and have other procedures such as blood pressure, and ECGs. On days where multiple blood samples are needed they will be collected through a catheter placed in the arm opposite the arm used for infusions. However if the catheter cannot be used blood samples will be collected by direct needle sticks. On days that require only a few blood samples they will be collected by direct needle sticks. You will be required to fast overnight (nothing but water) several times and eat the study required meals provided to you.
· On Day 9 (Day 12 in-house) you will be discharged from the research clinic about 24 hours after the end of your final infusion of study drug, blood samples and study procedures.
· On Day 10 (the Return Visit) (Day 13 after admission) you will return to the research clinic for an additional blood sample.
· On Day 11 (the Follow-up Visit) (Day 14 after admission) you will return for additional blood samples and procedures such as such as a physical exam.
The study procedures and schedule are explained in detail in the attached “Informed Consent Form”.
You can’t be in another research study at the same time or have been in one within 30 days before this study.
After the Screening Visit is on Thursday 07-Jan-2016 (times to be determined). The dates for the study are:
Group 1 (6 subjects)
Dosing Visit (In-patient): Check-in on Day -3 at 9 AM Friday 15-Jan-2016 and leave about 24 hours after the last study dose on Day 9 Tuesday 26-Jan-2016
Return Visit (Out-patient): Wednesday 27-Jan-2016
Follow-up Visit (Out-patient): Thursday 28-Jan-2016
Group 2 (6 subjects)
Dosing Visit (In-patient): Check-in on Day -3 at 9 AM Tuesday 02-Feb-2016 and leave about 24 hours after the last study dose on Day 9 Saturday 13-Feb-2016
Return Visit (Out-patient): Sunday 14-Feb-2016
Follow-up Visit (Out-patient): Monday 15-Feb-2016