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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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

Key facts

Study ID: NCT02013388
Run by: Nivalis Therapeutics, Inc.
People needed: 49
Starts: 2014-02-01
Expected to finish: 2015-02-01
Last updated by the study team: 2016-12-21

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

DaVita Clinical Research — Lakewood, Colorado, United States

Full record on ClinicalTrials.gov

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