A Safety Study of PTI-125 in Healthy Volunteers
Condition: Alzheimer Disease, Early Onset; Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: 50 mg PTI-125; 100 mg PTI-125; 200 mg PTI-125
Intervention description: PTI-125 50 mg Oral Solution; PTI-125 100 mg Oral Solution; PTI-125 200 mg Oral Solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single center, randomized, double-blind, placebo controlled, SAD study of three escalating doses of PTI-125. A total of 24 healthy subjects enrolled in one of three dose cohorts. Each cohort will contain 8 subjects; six receive PTI-125 and two receive placebo. Three SAD does of PTI-125 oral solution (50, 100 or 200 mg) or placebo solution will be administered.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single Ascending
      Dose, Pharmacokinetic and Safety Study of PTl-125 in Healthy Volunteers
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between 18 and 45 years of age, inclusive.

          -  The subject has a body mass index (BMI) within 18-30 kg/m2 (inclusive).

          -  The subject is in good health as determined by medical history and physical
             examination and clinical laboratory parameters.

          -  The subject is willing and able to speak, read, and understand English and provide
             written informed consent.

          -  The subject is a non-smoker for at least 12 months. If a former smoker, the reason for
             stopping must be evaluated.

          -  Females who are physically incapable of childbearing defined as postmenopausal, or
             surgically sterile (hysterectomy, bilateral tubal ligation, bilateral oophorectomy or
             an Essure procedure). Appropriate documentation (ex; medical record) of the surgical
             sterilization procedure to be obtained and held within the subject's study file.

          -  The subject must agree to comply with the drawing of blood samples for the PK
             assessments.

          -  The subject is willing and able to comply with all testing and requirements defined in
             the protocol.

          -  The subject is willing and able to remain at the study site unit for the duration of
             the confinement period and return for the outpatient visit.

        Exclusion Criteria:

          -  The subject has any relevant deviations from normal in physical examination,
             electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the
             investigator.

          -  The subject has had a clinically significant illness within 30 days of Check-in.

          -  The subject has a history of significant neurological, hepatic, renal, endocrine,
             cardiovascular, gastrointestinal, pulmonary, or metabolic disease.

          -  The subject has used any prescription medication within 14 days of dosing or overthe-
             counter (OTC) medication within 48 h of dosing or intends to use any prescription
             medication or OTC medication during the study that may interfere with the evaluation
             of study medication.

          -  The subject has used alcohol, caffeine or xanthine-containing products 48 h before
             dosing or intends to use any of these products during the study.

          -  The subject has used grapefruit, grapefruit juice, or grapefruit-containing products
             days before dosing or intends to use any of these products during the study.

          -  The subject has a history of substance abuse or a positive ethanol breath test, urine
             cotinine, or urine drug screen at screening or at check-in. The subject has a positive
             serum hepatitis B surface antigen or positive HCV antibody test at the Screening
             Visit.

          -  The subject has a positive HIV test at the Screening Visit.

          -  Female subject is pregnant or breastfeeding.

          -  The subject has received an investigational drug within 30 days of Check-in.

          -  The subject has donated or lost a significant volume of blood (>450 mL) within 4 weeks
             prior to the study.

          -  The subject is unwilling to reside in the study unit for the duration of the study or
             to cooperate fully with the investigator or site personnel.

          -  The subject has an AST/ALT or total bilirubin greater than the ULN. One repeat test
             will be allowed.