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

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nivalis Therapeutics, Inc.
• Collaborator: Davita Clinical Research
• Treatments: Rifampin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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