MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects
Condition: Healthy
Intervention: N91115; Placebo; N91115; Placebo-Day 1 only
Intervention description: Given PO daily for 14 days; Given PO daily for 14 days; Given PO only on Day 1; Given PO- only on Day 1 (single dosed to match single dose treatments)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: N91115; GSNORi; SNO; Cavosonstat

Summary:

      A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of
      N91115.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject voluntarily agrees to participate in this study and signs an Institutional
             Review Board (IRB)-approved informed consent prior to performing any of the screening
             procedures and in the opinion of the PI complies with all the requirements of the
             study.

          -  Subject is healthy, determined at the screening medical evaluation (including but not
             limited to medical history, physical examination and clinical laboratory evaluations).

          -  Subject is Caucasian.

          -  Female subject must be of non-childbearing potential (surgically sterile [hysterectomy
             or bilateral tubal ligation] or post-menopausal ≥ 1 year with follicle stimulating
             hormone [FSH] > 40 U/L). Women receiving hormone replacement therapy (HRT) are
             eligible to enroll.

          -  Male subject must agree to use condoms and refrain from sperm donation from Day 1
             until 30 days post last dose or have documentation of vasectomy.

          -  Subject has a body weight > 50 kg and body mass index (BMI) between 19.5 and 32 kg/m2,
             inclusive, at screening.

          -  Subject has no clinically significant abnormal findings related to their systolic or
             diastolic blood pressure (BP), per the investigator's judgment, at screening or Day 1.

          -  Subject has no clinically significant abnormal findings in 12 lead ECG, per the
             investigator's judgment, at screening.

        Exclusion Criteria:

          -  Subject has clinically significant history or evidence of cardiovascular, respiratory,
             hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or
             psychiatric disorder(s) as determined by the investigator or designee.

          -  Subject has clinically significant abnormalities on a 12 lead ECG done at screening

          -  Subject has clinically significant abnormalities on a 48-hour ambulatory ECG done at
             screening

          -  Subject has any disorder that would interfere with the absorption, distribution,
             metabolism, or excretion of drugs.

          -  Subject has any concurrent disease or condition that, in the opinion of the
             investigator, would make the subject unsuitable for participation in the clinical
             study.

          -  Subject is unlikely to comply with the protocol requirements, instructions, and study
             related restrictions; e.g., uncooperative attitude, unavailable for follow-up call,
             and/or improbability of completing the clinical study.