A Clinical Study to Determine Biomarkers of Response to a Gamma Secretase Inhibitor

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Comparator: Placebo; Drug: MK0752; Drug: Comparator: MK0752.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00803894

2008_594

0752-022

Details and patient eligibility

About

The purpose of this study is to determine the transcriptional signature of Notch Inhibition by testing hair and blood samples on healthy male volunteers who have received MK0752 vs placebo for possible future biomarkers in the treatment of cancer or Alzheimers Disease

Enrollment: 30 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient is a male
• Patient has no clinically significant abnormality on electrocardiogram performed
• Patient agrees to not to consume apple juice, grapefruit or grapefruit products beginning 2 weeks prior to first dose of study drug and for the duration of the study
• Patient has been a nonsmoker and/or has not used nicotine or nicotine-containing products for approximately 6 months.
• Patient is willing to not use any hair enhancement product or procedures for the duration of the study (for example, permanents, hair straightening techniques)
• Patient has a full head of hair
• Patient has at least 90% non-gray hair

Exclusion criteria

• Patient has had treatment with any investigational therapy during the prior 21 days
• Patient has any history of significant gastrointestinal abnormalities within the last 10 years
• Patient has a history of any long-term or active liver disease including elevated liver blood tests. Any patient with a history of Hepatitis B or C (and/or treated previously) will be excluded
• Patient has a known history or family history of aortic valve disease, congenital (from birth) heart disease or deafness, hearing loss or early onset Alzheimer's disease (onset at age < 55)
• Patient has a known sensitivity to the ingredients in the drug
• Patient has had active and uncontrolled infection within the past month
• Patient is HIV positive
• Patient has a history of stomach, intestine, heart, blood, liver, brain, kidney, lung, bladder or endocrine abnormalities or diseases
• Patient has a history of cancer except for certain skin cancer (basal cell)
• Patient has a history of multiple and/or severe allergies or has had an allergic reaction to food or prescription/non-prescription drugs
• Patient has had major surgery, donated or lost 1 unit of blood (about 500 mL) within the past month
• Patient has premature graying hair (> 10% gray hair)
• Patient has male pattern hair loss
• Patient has a prior history of high blood pressure
• Patient uses any medication, including prescription and non-prescription drugs or herbal remedies (such as St. John's Wort) beginning approximately 2 weeks prior to the first dose of study drug, throughout the study until the post study visit
• Patient consumes excessive amounts of alcohol (greater than 3 glasses of alcoholic beverages)
• Patient consumes excessive amounts (greater than 6 servings) of coffee, tea, cola or other caffeinated beverages per day
• Patient is a regular use (including "recreational use") of any illicit drugs, has a positive urine drug screen before randomization or has a history of drug (including alcohol) abuse within approximately the past 2 years
• Patient has prior exposure to MK 0752 with the past 21 days

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

A

Active Comparator group

Description:

MK0752 1000 mg

Treatment:

Drug: MK0752

B

Active Comparator group

Description:

MK0752 350 mg

Treatment:

Drug: Comparator: MK0752.

C

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo