Study 1202 - Participants with High Blood Pressure Needed

Research Study Purpose:  The purpose of this study is to:

• Test the safety of an investigational drug when given to individuals with high blood pressure
• Determine the side effects of a single dose of the investigational drug when injected under the skin
• Determine how long the investigational drug lasts in the body
• Determine the effect of the investigational drug on lowering blood pressure

Minimum Participant Qualifications:

• Men and Women
• Ages 18-70
• Has been diagnosed with high blood pressure
• Body Mass Index (BMI) between 20 to 40
• No history of significant heart disease
• Not have Hepatitis B, C, and HIV
• No history of drug/alcohol abuse in past 12 months
• Must test negative for alcohol and drugs of abuse

Length:  The length of time participants will be in this study will vary according to the individual's medical history.  Volunteers who meet study eligibility requirements after screening period will be required to have a minimum of 2 morning visits prior to dosing with the investigational drug, 1 inpatient stay of 3-4 overnights (72-96 hours) and 6 morning outpatient visits.

Compensation will be provided for study participation.

For more information about this research study, please contact Kevin at:

651-641-2911 or www.prismresearchinc.com

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Study 1122 - Part 1 - Healthy Participants Needed

Research Purpose:  To evaluate the safety and tolerability of a single dose of an investigational drug in healthy volunteers that is being developed for the prevention of weight loss associate with individuals suffering from lung cancer.

Minimum Participant Qualifications:

• Healthy Men and Women
• Women must be surgically sterilized, post menopausal practicing contraception or sexually inactive
• Age 18-55
• Body Mass Index 18-32; weight between 110-220 lbs.
• No tobacco use in the past year.
• No active history of significant medical conditions.
• Must test negative for drugs of abuse; No history of drug or alcohol abuse.
• No use of prescription medications within the 48 hours prior to the start of the study with the exception of oral contraceptives.
• Must be able to swallow tablets

Study Length:  For those who qualify for the study based on screening results, this study consists of 1 inpatient stay and 1 outpatient visit.  The inpatient stay requires 3 overnights (approximately 65 hours).  The outpatient visits will last about an hour.  Total participation time after screening is approximately 2½ weeks.

Compensation:  up to $850.00

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Study 907 - Healthy Participants Needed

Research Purpose:  The purpose of this study/screening visit is to identify and obtain baseline information on people with a genetic trait for the cytochrome P450 enzymes CYP2C19 and CYP2D6.  These enzymes can affect how drugs are eliminated from the body.  The information obtained in the study/screening visit may be used to identify you for possible participation in future studies at Prism Research.

Minimum Participant Qualifications:

• Men and Women of all races
• Ages 18-65
• Must speak English

Length:  One 1-hour outpatient visit that will include a review of your medical history, medications, brief physical examination and a blood sample.

Compensation:  Up to $25

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Study 1109 - Healthy Participants Needed

Research Purpose:  To evaluate the safety, tolerability and immune response of an investigational vaccine being developed for the prevention of infections caused by Staphylococcus aureus.

Participant Qualifications:

• Men and Women ages 18-64
• Must be in good health; chronic or ongoing medical conditions must be stable and will be accepted on a case by case basis.
• Must not be diagnosed with any conditions related to prolonged bleeding or immunosuppression.
• No history of anaphylactic reaction to vaccinations
• No history of receipt of a S. Aureus vaccine.
• No receipt of blood products or immunoglobulins (including monoclonal antibodies) within 12 months before enrollment through conclusion of the study.
• No women who are pregnant, planning to become pregnant during the duration of the study, or who are breast feeding.
• All male and female subjects who are biologically capable of having children must use a reliable method of birth control for the duration of the study.
• Must have a reliable home or personal cell phone.

Study Length:  Participants who pass the screening visit will participate in approximately 10 outpatient visits over the course of 12 months (one calendar year).

Compensation:  up to $750

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Study 1110 - Participants with Reduced Kidney Function Needed

Research Purpose:  To evaluate the absorption/elimination rate and tolerability of a single intravenous dose of an investigational drug being developed for the treatment of serious infections when it is administered to participants with various degrees of kidney impairment compared to healthy volunteers with normal renal function.

Minimal Participant Qualifications: 

• Men and Women ages 18-75
• Body Mass Index between 19-32 kg/m²; and must weigh at least 88 pounds.
• Must have reduced kidney function
• No history of HIV, hepatitis B or C
• No presence of a functioning organ transplant
• No history of significant hearing loss or a family history of hearing loss (excluding age related hearing loss defined as experienced by those 65 years and older)
• Any preexisting medical conditions other than those listed above must be well controlled and participation will be approved on a case by case basis
• Must be able and willing to abstain from all alcohol consumption throughout the duration of the study

Study Length and Compensation:  For those who pass the screening process, the study will consist of one, 3½ day long inpatient stay (3 overnights total) and 3 outpatient visits. Total participation time following screening is approximately two weeks.

Compensation:  up to $1175.00

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Study 1120 - Participants with Type 2 Diabetes Needed for a Research Study - UPDATED

Research Purpose:  To evaluate the absorption/elimination rates of two different concentrations of an investigational injected medication being developed for individuals with high blood sugar when administered as a subcutaneous injection in participants with Type 2 Diabetes.

Minimal Participant Qualifications:

• Men and Women with a diagnosis of Type 2 Diabetes for at least 6 months
• Age: 18-75 years
• Women must be using an approved birth control method (hormonal contraceptives are allowed) or be post-menopausal or surgically sterilized
• Cannot be taking insulin, Byetta^®, or Victoza^® (additional excluded medications may apply)
• No history of alcohol or drug abuse within the past 12 months.  Must test negative for alcohol and illicit drugs.
• No history of unstable cardiac disease, pancreatitis, severe gastrointestinal disease, hepatitis B or C, or HIV.
• Presence or history of any medical condition not listed above must be stable and well-controlled and will be considered on a case by case basis.

Study Length:  For those who qualify to participate based on screening evaluations, the study will consist of two approximately 28-hour inpatient stays (one overnight each) and 13 outpatient visits.  The total participation time after screening is approximately 6 weeks.

Study participants will be compensated for their time and travel.

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Participants on Hemodialysis

Prism Research is currently recruiting participants on hemodialysis for multiple research studies, who also meet the following criteria:

• Ages 18-80
• Body Mass Index between 18-40 kg/m²
• Willing and able to abstain from alcohol and tobacco use for specified time periods
• Negative for HIV and Hepatitis B or C

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Study 1112 - Participants with Reduced Kidney Function or on Dialysis Needed

Research Purpose:  To evaluate the safety, tolerability and absorption/elimination rates of an investigational medication being developed for the treatment of spasticity when administered to participants with various degrees of reduced kidney function including participants on dialysis.

Minimal Participant Qualifications:

• Male and female
• Age: 18-80 years
• Must have mild, moderate or severe kidney impairment, or must be stable on dialysis treatment for 3 months.
• Body Mass Index less than or equal to 35 kg/m².
• Women must be post-menopausal, surgically sterilized or using an effective form of birth control.  Hormonal birth control is allowed.
• Must test negative for illegal drugs and alcohol at study screen.  No history of drug or alcohol addiction or abuse in the two years prior to study screen.
• Must not have a functioning kidney transplant.
• No history of suicidal behavior or suicidal thoughts.
• No history of seizures/seizure disorder.
• No history of Hepatitis B or HIV.
• Must be able and willing to abstain from alcohol 72 hours prior to study drug dosing throughout the duration of the study.
• Diagnosis of medical conditions other than reduced kidney function and related conditions will be reviewed and accepted on a case by case basis.

Study Length and Compensation:  For those who pass the screening visit, the study requires 1 inpatient stay and 1 outpatient visit as indicated below:

Participants with Mild, Moderate and Severe Renal Impairment:  Approximately a two-week long study requiring 1 inpatient stay of 8 overnights and 1 outpatient visit.  Compensation up to $2100.

Participants Receiving Dialysis:  Approximately a 1½-week long study requiring 1 inpatient stay of 3 overnights and 1 outpatient visit.  Compensation up to $850.

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Study 1118 - Healthy Participants Needed

Research Purpose:  To test blood samples collected from healthy adults of varying ages and racial backgrounds in order to establish the reference (normal) range for a laboratory procedure that helps to assess if a person is having a heart attack.

Minimal Participant Qualifications:

• Healthy Men and Women
• Must be African-American or Asian (the Caucasian group has been filled)
• No history of cardiac disease
• No chronic use of medications for heart conditions
• No surgery within one month of the study
• Have not recently experienced any blunt force trauma
• Must hot have engaged in extreme exercise within 3 days of the study (examples of extreme exercise include participating in a marathon or triathlon or participation in high intensity workouts, e.g. bootcamps, eccentric weight training)

Study Length:  Only one outpatient visit required: approximately 2 hours in length.

Compensation:  Up to $50.00

For more information about this research, please contact:

651-641-2908 or prismresearchinc.com

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Study 1127 - Participants with Kidney Disease Needed

Research Purpose:  To evaluate the absorption/elimination rates of an investigational injected drug in people with severe kidney dysfunction not yet on dialysis.  The investigational drug is being developed for individuals with Type 2 Diabetes.

Minimal Participant Qualifications:

• Men and Women with severe kidney impairment
• Age: 18-79 years
• Body Mass Index (BMI) 19-40 and weighing at least 99 pounds
• Participants cannot be taking or have used Byetta^® or Victoza^® in the past year (additional excluded medications may apply)
• No history of alcohol or drug abuse within the past 12 months.  Must test negative for alcohol and illicit drugs.
• No history of unstable cardiac disease, pancreatitis, severe gastrointestinal disease, hepatitis B or C, or HIV.
• Presence or history of any medical condition not listed above must be stable and well-controlled and will be considered on a case by case basis.

Study Length:  For those who qualify to participate based on screening evaluations, the study will consist of one approximately 3-day inpatient stay and 7 morning outpatient visits.  The total participation time after screening is approximately 4 weeks.

Compensation:  up to $1350.00 for study participation time.

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Study 1200 - Healthy Participants Needed

Research Purpose:  A new way to manufacture the FDA approved drug Avonex^® (Interferon beta -1a) has been developed.  The purpose of the study is to compare the metabolism of Avonex^® after a single dose manufactured by the current process and after a single dose manufactured by the new process, when administered to healthy participants.

Minimum Participant Qualifications:

• Healthy Men and Women
• Ages 18-45
• Must weigh at least 110 pounds and have a Body Mass Index (BMI) of 18.5-30
• No flu-like illnesses (e.g., fever, upper respiratory infection, common cold) within one week of first day of study.
• No blood donations within 1 month prior to first day of study.
• No vaccinations within 4 weeks prior to first day of study
• No regular use of prescription or non-prescription medications (Exceptions:  acetaminophen, ibuprofen, naproxen, aspirin, hormonal birth control and hormone replacement therapy)
• No history of severe allergic or anaphylactic reaction to any drug.
• Must test negative for drugs.  No history of drug or alcohol abuse within 6 months prior to screening appointment.
• Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information.

Length:  Participants who pass the screening evaluations will be enrolled into an approximately 6-week long study requiring two periods.  Each period will consist of a three-day inpatient stay followed by three brief outpatient visits, and one final follow-up phone call.  The inpatient stays are separated by 5 days.

Compensation:  up to $1975.00 for study participation time.

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Study 1119 - Healthy Participants Needed

Research Purpose:  To test blood samples collected from healthy adults of varying ages in order to establish the reference (normal) range for a laboratory procedure that helps indicate the presence of certain diseases or disorders.

Minimum Participant Qualifications:

• Healthy Men and Women between the ages of 21 to 79 years old
• No hospitalization 6 months prior to study entry
• No significant illness 6 months prior to study entry
• Females currently lactating or pregnant cannot participat in this study

Study Length:  Only one outpatient visit required, approximately 2 hours in length.

Compensation:  Up to $50.00

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Study 1123 - Participants with Type 2 Diabetes Needed

Research Purpose:  To evaluate the absorption/elimination rate, safety, and tolerability of an oral dose of an investigational drug being developed for the management of glycemic control in patients diagnosed with Type 2 Diabetes.

Minimal Participant Qualifications:

• Men and Women ages 18-75 diagnosed with Type 2 Diabetes for at least 3 months prior to screening.
• Must be taking a stable dose of Metformin greater or equal to 1000 mg/day for management of diabetes for at least 4 weeks prior to start of study.
• Body Mass Index between 20-40 kg/m²
• No insulin use 6 months prior to screening
• No history of pancreatitis, epilepsy, stroke, myocardial infarction or congestive heart failure
• No history of gastrointestinal surgery for obesity
• Participants with other pre-existing medical conditions may be excluded; participation will be approved on a case by case basis
• Must be able and willing to abstain from all caffeine and grapefruit consumption throughout the duration of the study

Study Length and Compensation:  For those who pass the screening process, the study will consist of:

• One 8½ day long inpatient stay (8 overnights total)
• Two 7½ day long inpatient stays (7 overnights each) and 3 outpatient visits.

Compensation:  up to $5675.00 for time associated with study participation

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Study 1129 - Participants with Reduced Kidney Function Needed

Research Purpose:  To evaluate the absorption/elimination rate and tolerability of a single oral dose of an investigational drug being developed for the treatment of certain cancers when it is administered to participants with various degrees of kidney impairment compared to healthy volunteers with normal renal function.

Minimum Participant Qualifications:

• Men and Women ages 18-65
• Body Mass Index between 18-40 kg/m²; and must weight at least 110 pounds.
• Must have reduced kidney function
• Cannot be taking herbal supplements or hormone replacement therapy
• Any preexisting medical conditions other than those listed above must be well controlled and participation will be approved on a case by case basis
• Must be able and willing to abstain from all alcohol and caffeine consumption throughout the duration of the study
• Must be able and willing to abstain from eating or drinking grapefruit and grapefruit related citrus fruits throughout the duration of the study.

Study Length and Compensation:  For those who pass the screening process, the study will consist of one, 6½ day long inpatient stay (6 overnights total) and 2 outpatient visits.  Total participation time following screening is approximately four weeks.

Compensation: up to $1725.00

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Study 1207 - Participants with High Cholesterol

Protocol: AMG 145 20110109

Daniel K. Ries, MD

Prism Research

Do You Have High Cholesterol?

Do you have high cholesterol? Prism Research is currently conducting a research study to evaluate an investigational medication for individuals with high cholesterol.

You may be eligible if:

• You are 18 - 75 years of age
• If you have high LDL (bad cholesterol)
• If you have been advised to make dietary and lifestyle modifications due to elevated cholesterol
• If your primary care physician is monitoring your cholesterol levels

Qualified participants will received study related medication and study related medical exams.  All costs not related to the study, including those related to the normal treatment of your condition will be your responsibility. If qualified, compensation for time and travel is available.

For more information call:

Prism Research

(651) 641-2908

whaessly@prismresearchinc.com

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