Study 1305 - Participants with Kidney Disease Needed

RESEARCH PURPOSE: To study how a new investigational drug being developed for the treatment of high cholesterol is absorbed and eliminated from the body in patients with low kidney function.

BASIC PARTICIPANT QUALIFICATIONS:

• Men and women with severe kidney impairment
• Age between 18-85 yrs old
• Women must be postmenopausal or surgically unable to become pregnant
• BMI between 18-40
• Stable and controlled medical conditions
• All medicines will be reviewed before qualification is determined
• No history of HIV, Hepatitis B or Hepatitis C
• Able and willing to eat/drink or avoid study specific foods/beverages

STUDY LENGTH: One 3 night-4 day overnight stay period followed by 7 outpatient visits and 1 follow-up visit.  Total timeframe is approximately 30 days, not including a screening visit.

COMPENSATION: Up to $1425.00

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STUDY 1307 - Participants with Type 2 Diabetes Needed

RESEARCH STUDY PURPOSE:  To learn about the safety and tolerance of an investigational injectable drug being developed for the treatment of Type 2 Diabetes and determine how the drug enters the blood stream, moves through, and is eliminated from the body in people diagnosed with Type 2 Diabetes.

BASIC PARTICIPANT QUALIFICATIONS:

• Men and Women aged 18 and older
• Body mass index (BMI) of 45 or less
• Diagnosed with Type 2 Diabetes
• Currently on basal insulin (Lantus) and at least 1 other oral diabetes medication
• All current medications will be reviewed before qualification is determined
• Both men and women, if able to conceive, must use an effective birth control method
• No history of HIV, Hepatitis B or Hepatitis C
• No history of cancer within 5 years of study participation (exceptions for treated basal/squamous cell or cervical carcinoma)
• Must not have had history of alcohol abuse or illegal drug use within 1 year of study participation

STUDY LENGTH:  One initial screen visit to determine qualification will be scheduled up to 45 days before study dose.  Qualified participants will attend 3 outpatient visits, 1 stay in the study unit for 4 days and 3 nights followed by an additional 7 outpatient visits.  Total study time frame is approximately 6 months.

COMPENSATION:  Up to $ 1600.00

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Study 1312 - Healthy Men and Women Needed

RESEARCH PURPOSE:  To learn about the safety and absorption/elimination rates of an investigational new inflammatory disease drug given as an injection in Healthy Volunteers.

BASIC QUALIFICATIONS:

• Healthy men and women aged 18-55
• Males body weight between 122--220lbs
• Females body weight between 100--198lbs
• No History of Drug or Alcohol Abuse
• Not diagnosed with Hepatitis B, Hepatitis C, or HIV
• Cannot have donated blood in 2 months before study start
• Able and willing to stop tobacco use for length of study

STUDY LENGTH: Total study timeframe is approximately 70 days to complete.  If you qualify based on an initial screen visit you will come back for an overnight stay of 2 nights/3 days, and return for 16 brief outpatient visits spread out over the 70 day timeframe.

COMPENSATION:  Up to $2,300.00

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Study 1228 - Participants with Kidney Disease

RESEARCH PURPOSE: To evaluate how a single oral dose of an investigational drug is absorbed, eliminated, and tolerated in people with varying degrees of impaired kidney function. The investigational drug is being developed for people with Myelofibrosis, a condition that causes blood cells to grow abnormally in the bone marrow.

MINIMUM PARTICIPANT QUALIFICATIONS:

• 18-75 years old
• Females must weigh 88-220 pounds
• Males must weight 110-253 pounds
• Prescription and over-the-counter medication use must be at stable doses and will be considered on a case by case basis; certain drugs and herbal agents will not be allowed
• No history of frequent headaches
• Smokers who use less than one pack a day will be considered for participation but must be willing and able to refrain from smoking at specific times as required by the study procedures
• Must test negative for alcohol and illicit drugs

STUDY LENGTH: One 4-night inpatient stay at the clinical research unit followed by 6 brief outpatient visits over the next 12 days.

COMPENSATION: Up to $1525.00 for study participation time

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Study 1212 - Healthy Men and Women Needed

RESEARCH PURPOSE:  The purpose of the  study is to learn more about the safety and effectiveness of a new investigational anti-Rabies immune globulin (passive antibodies) compared to a similar FDA-approved anti-Rabies product when given in conjunction with an anti-Rabies vaccine (as part of standard preventative treatment) in healthy participants.

BASIC QUALIFICATIONS:

• Healthy men and women 18 and older
• Must not have diagnosis of anything to do with the heart, kidney, brain, bone, blood, immune system, or conditions like diabetes or other major illnesses
• No previous exposure to Rabies, Rabies vaccine, or other Rabies treatments
• Cannot have history of cancer for 3 years--exception for basal or squamous cell skin cancer or situ cervical carcinoma
• Not diagnosed with Hepatitis C, Hepatits B, or HIV
• Ability to complete a home diary
• Must have no history of severe allergic reaction to plasma related products

STUDY LENGTH: Total study timeframe is approx. 6 1/2 months to complete.  If you qualify based on an initial screen visit you will come back for 7 outpatient visits spread out over the 6 1/2 month timeframe.

COMPENSATION: Up to $1,000.00

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Study 1302 - Participants with Kidney Disease Needed

RESEARCH PURPOSE: To learn more about the absorption, elimination and safety of an investigational new drug being developed for the treatment of Alzheimer's disease and Bipolar Disorder Type I. This drug is being tested in patients with varying degrees of kidney impairment.

BASIC PARTICIPANT QUALIFICATIONS:

• Men and Women with Mild, Moderate, and Severe kidney function
• Between the ages of 18-75
• BMI between 18-38
• Have not had a history of cancer within 5 years
• Non-smokers or smokers who use less than 1 pack per day in last 12 months
• No use of illegal drugs 3 months prior or during study
• Cannot have history of alcoholism or drug addiction within 2 years
• Not diagnosed with HIV, Hepatitis B or Hepatitis C

STUDY LENGTH: This study will involve approximately 4 study visits and two phone calls over a period up to six weeks. Included is an overnight visit of 2 nights and 3 days.

COMPENSATION: Up to $750 for study participation time

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Study 1303 - Participants with Kidney Disease Needed

RESEARCH STUDY PURPOSE: To study how an investigational drug being developed for the treatment of hepatitis C virus infection is absorbed and eliminated from the body in people with chronic kidney disease.

BASIC PARTICIPANT QUALIFICATIONS:

• Stage 4 chronic kidney disease
• Age 18-79
• BMI between 18-36
• Both men and women, if able to conceive, must be using effective birth control method
• Must have stable kidney function for 6 months prior to screen visit
• All current medications will be reviewed before qualification is determined
• No history of HIV, Hepatitis B, or Hepatitis C
• Able and willing to eat/drink or avoid study specific foods/beverages

STUDY LENGTH:  One nine-day overnight stay followed by 1 final outpatient visit 2-7 days later.  If qualified a screening visit will be scheduled within 28 days of the overnight stay.

COMPENSATION: Up to $2650.00

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