Safety, Tolerability and Pharmacokinetics Study of MK-7252 in Healthy Adult Participants (MK-7252-001)
Condition: Pharmacokinetics; Cancer
Intervention: MK-7252; Placebo
Intervention description: 1 mg/mL or 20 mg/mL of powder for oral suspension administered with a water volume that brings the total ingested volume to approximately 240 mL; Placebo powder for oral suspension administered with a water volume that brings the total ingested volume to approximately 240 mL
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of
      MK-7252 in healthy adults. Participants receive ascending doses of MK-7252 over five
      treatment periods. Each treatment period is separated by a 7-day washout period.

      Upon review of the interim safety and preliminary PK data of human exposure to date, Protocol
      Amendment 3 includes a third panel of participants, Panel C, to assess the PK of higher doses
      of MK-7252 and to assess the food effect of MK-7252.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants of non-childbearing potential (Note: If postmenopausal
             female: participant is without menses for at least 1 year and has a documented
             follicle stimulating hormone [FSH] level in the postmenopausal range at pre-trial
             [screening] - OR - If surgically sterile female: participant is status post
             hysterectomy, oophorectomy or tubal ligation.)

          -  Body Mass Index (BMI) between 18.5 and 32 kg/m^2, inclusive. BMI = weight (kg)/height
             (m)^2.

          -  While in semi-recumbent position, has a systolic blood pressure ≤140 mmHg and
             diastolic blood pressure ≤90 mm Hg and a respiratory rate ≤20 breaths/min at the
             pre-study (screening) visit and prior to randomization.

          -  Judged to be in good health based on medical history, physical examination, vital sign
             measurements and electrocardiogram (ECG) performed prior to randomization.

          -  Non-smoker and/or has not used nicotine or nicotine-containing products (e.g.,
             nicotine patch) for at least approximately 3 months.

        Exclusion Criteria:

          -  Mentally or legally incapacitated, has significant emotional problems at the time of
             pretrial (screening) visit or expected during the conduct of the study or has a
             history of clinically significant psychiatric disorder of the last 5 years.

          -  History of clinically significant endocrine, gastrointestinal, cardiovascular,
             hematological, hepatic, immunological, renal, respiratory, genitourinary or major
             neurological (including stroke and chronic seizures) abnormalities or diseases.

          -  History of liver disease (chronic hepatitis, cirrhosis, etc.).

          -  History of cancer (malignancy). Exceptions include adequately treated non-melanomatous
             skin carcinoma or carcinoma in situ of the cervix and other malignancies which have
             been successfully treated ≥10 years prior to the pre-study (screening) visit.

          -  History of significant multiple and/or severe allergies (e.g. food, drug, latex
             allergy), or has had an anaphylactic reaction or significant intolerability (i.e.
             systemic allergic reaction) to prescription or non-prescription drugs or food.

          -  Tests positive for hepatitis B surface antigen, hepatitis C antibodies or human
             immunodeficiency virus (HIV).

          -  Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4
             weeks prior to the pre-study (screening) visit.

          -  Participated in another investigational study within 4 weeks (or 5 half-lives),
             whichever is greater, prior to the pre-study (screening) visit.

          -  QTc interval ≥470 msec (for males) and ≥480 msec (for females).

          -  Taken a Proton Pump Inhibitor (PPI) during the 5 days prior to start of study
             treatment.

          -  Unable to refrain from or anticipates the use of any medication, including
             prescription and non-prescription drugs or herbal remedies beginning approximately 2
             weeks (or 5 half-lives) prior to administration of the initial dose of study drug,
             throughout the study (including washout intervals between treatment periods), until
             the post-study visit.

          -  Consumes >3 glasses of alcoholic beverages (1 glass is approximately equivalent to:
             beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1
             ounce]) per day.

          -  Consumes excessive amounts, defined as >6 servings (1 serving is approximately
             equivalent to 120 mg of caffeine) of coffee, tea, cola, energy-drinks, or other
             caffeinated beverages per day.

          -  Regular user of cannabis, any illicit drugs or has a history of drug (including
             alcohol) abuse within approximately 1 year. Participants must have a negative result
             for urine drug screen test prior to randomization.