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Drug & research development » Clinical trials » NCT02013388

MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects (SNO2)

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects

Clinical Trials gov number: NCT02013388

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

Phase: 1

Type: Interventional, randomized, double-blind, parallel assignment

Study sponsor: Nivalis Therapeutics, Inc.

  • 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
  • Healthy, determined at the screening medical evaluation (including but not limited to medical history, physical examination and clinical laboratory evaluations)
  • 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.

Body weight >50 kg and body mass index (BMI) between 19.5 and 32 kg/m2, inclusive, at screening.

No clinically significant abnormal findings related to their systolic or diastolic blood pressure (BP), per the investigator’s judgment, at screening or Day 1.

No clinically significant abnormal findings in 12 lead ECG, per the investigator’s judgment, at screening.

Intervention
N91115

Geographical Location
United States

Number of Participants
≤50 (18-55 years)

Primary Endpoint

Safety and Tolerability of N91115 [ 21 Days ]
Pharmacokinetics: Day 1 AUClast, Plasma Cmax Values
Pharmacokinetics: Day 14 AUCtau, Plasma Cmax Values

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  • Experimental: 10 mg single oral daily dose of 10 mg N91115 for 14 days
  • Placebo Comparator: Placebo single oral daily dose of placebo for 14 days
  • Experimental: 50 mg  single oral daily dose of 50 mg N91115 for 14 days
  • Experimental: 50 mg (single dose) single oral dose of 50 mg N91115
  • Experimental: 250 mg single oral daily dose of 250 mg N91115 for 14 days (fasted)
  • Experimental: 250 mg (Fed) single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)
  • Experimental: 500 mg single oral daily dose of 500 mg N91115 for 14 days
  • Placebo Comparator: Placebo-Day 1 only Single oral dose of placebo (Day 1 only)
View Trial Results