MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects

Phase 1

Completed

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

Detailed Description: This Phase 1 study in healthy subjects is being conducted to assess the safety, tolerability, and pharmacokinetics of N91115. Also, a comparison of the fasted versus fed with a high fat meal were compared for PK.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
50 mg (single dose)	N91115	single oral dose of 50 mg N91115
Placebo	Placebo	single oral daily dose of placebo for 14 days
50 mg	N91115	single oral daily dose of 50 mg N91115 for 14 days
Placebo-Day 1 only	Placebo-Day 1 only	Single oral dose of placebo (Day 1 only)
250 mg (Fed)	N91115	single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)
500 mg	N91115	single oral daily dose of 500 mg N91115 for 14 days
250 mg	N91115	single oral daily dose of 250 mg N91115 for 14 days (fasted)
10 mg	N91115	single oral daily dose of 10 mg N91115 for 14 days

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: AUCtau Day 14	Day 14	Plasma analysis of AUCtau values from the end of the dosing period (Day 14) with N91115
Safety and Tolerability of N91115	21 Days	Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.
Pharmacokinetics: Day 1 Plasma Cmax Values	Day 1	All subjects who completed sample collections for Day 1 plasma N91115
Pharmacokinetics: Plasma Cmax Values on Day 14	Day 14	Plasma Cmax values from Day 14 subjects with repeat administration of N91115
Pharmacokinetics: Day 1 AUClast	Day 1	Day 1 AUClast plasma values from treatment groups completing 14 days of N91115 administration