Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy Volunteers
Condition: Healthy Adult Subjects; Healthy Elderly Subjects
Intervention: BIIB118; Melatonin
Intervention description: Multiple ascending doses of BIIB118 (50 mg, 150 mg, 450 mg and 900 mg) as extemporaneously prepared solution/suspension administered once daily over 2 weeks; Positive control used to assess the validity of DLMO as pharmacodynamic endpoint.
Intervention MeSH terms: Melatonin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Multiple Ascending Dose Study; Safety and Tolerability; Pharmacokinetics; Pharmacodynamics; Melatonin; Plasma; Dim Light Melatonin Onset

Summary:

      This is the first clinical trial to evaluate ascending multiple oral doses in healthy adult
      and healthy elderly subjects to characterize the safety, tolerability, pharmacokinetics (PK)
      and pharmacodynamics (PD) of BIIB118
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female subjects of non-childbearing potential between the ages of
             18 and 55 years (Parts A and B) or 65 and 85 years (Part C), 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.