A Randomized Clinical Trial to Study the Effects of MK0752 Versus Placebo on Biomarkers in Healthy Young Adult Male Subjects
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