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

Phase 1
18 Years
35 Years
Not Enrolling

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Trial Information

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Time Frame:

8.5 hours post dose.

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2008

Completion Date:

May 2009

Related Keywords:

  • Healthy
  • Biomarkers of Notch inhibition