Healthy
Conditions
Keywords
Biomarkers of Notch inhibition
Brief summary
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
Interventions
DRUGMK0752
Single dose MK0752 capsules, 1000 mg: there will be a 7-day washout period between treatments.
DRUGComparator: MK0752.
Single dose MK0752 capsules, 350 mg: there will be a 7-day washout period between treatments.
DRUGComparator: Placebo
Single dose placebo capsules: there will be a 7-day washout period between treatments.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the existing Notch response signature using plucked hair follicle profiling data from health young male volunteers given 1000 mg MK0752 and 350 mg MK0752. | 8.5 hours post dose. |
Outcome results
None listed