A Drug-Drug Interaction Study of N91115 +/- Rifampin in Healthy Adult Subjects

Completed · Phase 1

Conditions studied: Drug Interaction Potentiation

In brief

The present study is designed to assess the effects of Rifampin on the pharmacokinetics of N91115 in healthy subjects.

Key facts

Study ID

NCT02500667

Run by

Nivalis Therapeutics, Inc.

People needed

15

Starts

2015-06-01

Expected to finish

2015-08-01

Last updated by the study team

2016-11-07

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; signs an IRB-approved informed consent
• Subject is healthy as determined by 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 or post-menopausal
• Male subject must agree to use a condom with spermicide and refrain from sperm donation from Day -1 until 30 days post last dose or have a vasectomy at least 6 months prior to screening
• Subject is a non-smoker
• Subject has a body weight > 45 kg and BMI between 18 and 32 kg/m2
• Subject has no clinically significant vital signs finding at screening or Day -1, per the investigator's judgment
• 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)
• Subject has abnormal 12-lead ECG at screening per protocol
• 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 a current alcohol abuser and/or has a history of illicit drug abuse within 1 year prior to dosing
• Subject has a positive screening test for Hepatitis B surface antigen, Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody
• Subject is unwilling to refrain from consumption of coffee and caffeine-containing foods and beverages from Day -1 until discharge on Day 14
• Subject is unwilling to abstain from using alcohol beverages from Day -1 until discharge on Day 14
• Subject has donated blood (> 500 mL) or blood products within 56 days prior to Day -1
• Subject has used over-the-counter (OTC) medications (including vitamins) from Day -7, or prescription medications, or herbal remedies from Day -14 until end-of-study follow-up call. By exception, acetaminophen ≤ 1000 mg/day is permitted except within 48 hours prior to Day -1 and hormone replacement therapy (HRT) is allowed throughout the study
• Subject has used an investigational drug within 30 days prior to Day 1 dosing
• Subject has a history of bleeding disorders

Where it is running

• St. Anthony's Medical Plaza 1 — Lakewood, Colorado, United States

Full record on ClinicalTrials.gov

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