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

Study Overview
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Brief Summary
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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

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: MK0752
* Drug: Comparator: MK0752.
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>MK0752 1000 mg | Drug: MK0752<br>* Single dose MK0752 capsules, 1000 mg: there will be a 7-day washout period between treatments.<br>|
| Active Comparator: B<br>MK0752 350 mg | Drug: Comparator: MK0752.<br>* Single dose MK0752 capsules, 350 mg: there will be a 7-day washout period between treatments.<br>* Other names: MK0752;|
| Placebo Comparator: C<br>Placebo | Drug: Comparator: Placebo<br>* Single dose placebo capsules: there will be a 7-day washout period between treatments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarkers of Notch inhibition