Safety, Tolerability and Pharmacokinetics of BIIB118 (PF-05251749)
Condition: Healthy
Intervention: BIIB118; BIIB118; BIIB118
Intervention description: Single ascending doses of BIIB118 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 3 mg, 30 mg, 200 mg, 800 mg and placebo; Single ascending doses of BIIB118 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 10 mg, 100 mg, 400 mg, and placebo; Single dose (Maximum Tolerated Dose) of BIIB118 as extemporaneously prepared solution/suspension
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: First in human; Single Ascending Dose Study; Safety and Tolerability; Pharmacokinetics; Plasma; Cerebrospinal Fluid

Summary:

      This is a First in human (FIH) single ascending dose study to evaluate the safety,
      tolerability and pharmacokinetics (PKs) of BIIB118 following single oral doses in healthy
      human subjects
    

Eligibility criteria:

        Inclusion Criteria:

        •Healthy male and/or female subjects of non-childbearing potential between the ages of 18
        and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities
        identified by a detailed medical history, full physical examination, including blood
        pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

        Female subjects of non-childbearing potential must meet at least one of the following
        criteria:

          1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at
             least 12 consecutive months with no alternative pathological or physiological cause;
             and have a serum follicle-stimulating hormone (FSH) level confirming the
             post-menopausal state;

          2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;

          3. Have medically confirmed ovarian failure. All other female subjects (including females
             with tubal ligations and females that do NOT have a documented hysterectomy, bilateral
             oophorectomy and/or ovarian failure) will be considered to be of childbearing
             potential.

               -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110
                  lbs).

               -  Evidence of a personally signed and dated informed consent document indicating
                  that the subject has been informed of all pertinent aspects of the study.

               -  Subjects who are willing and able to comply with scheduled visits, treatment
                  plan, laboratory tests, and other study procedures.

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,
             seasonal allergies at time of dosing).

          -  Treatment with an investigational drug within 30 days (or as determined by the local
             requirement) or 5 half-lives preceding the first dose of study medication (whichever
             is longer).

          -  Screening supine blood pressure >= 140 mm Hg (systolic) or >=90 mm Hg (diastolic),
             following at least 5 minutes of rest. If BP is >=140 mm Hg (systolic) or >=90 mm Hg
             (diastolic), repeat per local standard operating procedures (SOP). If orthostatic
             changes are present and deemed to be clinically significant by the investigator,
             Subject can be excluded.