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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02500667
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : November 7, 2016
Davita Clinical Research
Information provided by (Responsible Party):
Nivalis Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Drug Interaction Potentiation Drug: N91115 Drug: Rifampin Phase 1

Detailed Description:

This study will assess the effects of multiple oral dose administration of rifampin on the steady state plasma pharmacokinetics (PK) of N91115 in healthy subjects.

Eligible subjects (n=15) will receive oral doses of N91115 twice daily (approximately every 12 hours) on Study Days 1 through the morning of Day 13. On Study Days 8 through 12, rifampin administered 600 mg once daily will be added to the N91115 regimen. Study subjects will be monitored for safety while housed in the clinical research unit (CRU) until discharge on Day 14. Pharmacokinetics will be followed from Study Day 1 through Study Day 14. A follow-up phone call will be made on Day 20 (1 day). Participation of an individual subject may last up to approximately 48 days from the time of screening until the end-of-study follow-up call.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Open-label, Drug-Drug Interaction Study to Assess the Steady State Pharmacokinetics of N91115 Alone and in the Presence of Multiple Dose Administration of Rifampin in Healthy Adult Subjects (SNO-5)
Study Start Date : June 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
Drug Information available for: Rifampin

Arm Intervention/treatment
Experimental: N91115 + Rifampin
N91115 200 mg twice daily (BID) from Study Day 1- 13, Rifampin 600 mg once daily (QD) from Study Day 8 - 12
Drug: N91115
200 mg BID
Other Name: Cavosonstat

Drug: Rifampin
600 mg QD
Other Name: Rifadin

Primary Outcome Measures :
  1. Assess the Potential Effects of Rifampin on N91115 Steady State Area Under the Curve (AUC) Values [ Time Frame: On Study Day 14 ]
    To assess the effects of multiple oral dose administration of rifampin on the steady state AUC on Day 14 of N91115 in healthy subjects.

Secondary Outcome Measures :
  1. Effects of Rifampin on the AUC vs time of Metabolites of N91115 [ Time Frame: On Study Day 14 ]
    make a preliminary non statistical assessment on the effects of multiple oral dose administration of rifampin on steady state plasma PK of N91288 and metabolites, in healthy subjects

  2. The number of participants with adverse events [ Time Frame: Over the 21 days of the study ]
    To evaluate the safety and tolerability of multiple oral doses of N91115 in the presence and absence of multiple oral doses of rifampin

  3. Effects of Rifampin on N91115 and its Metabolites on Urine 12 Hour drug concentrations [ Time Frame: Day 14 assessment ]
    To make a preliminary non statistical assessment on the effects of multiple oral dose administration of rifampin on the 12 hour steady state urine PK of N91115 and its primary metabolites in healthy subjects

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02500667

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United States, Colorado
St. Anthony's Medical Plaza 1
Lakewood, Colorado, United States, 80228
Sponsors and Collaborators
Nivalis Therapeutics, Inc.
Davita Clinical Research
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Principal Investigator: Christopher Galloway, MD Davita Clinical Research
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nivalis Therapeutics, Inc. Identifier: NCT02500667    
Other Study ID Numbers: N91115-1H-04 (SNO-5)
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016
Keywords provided by Nivalis Therapeutics, Inc.:
drug interaction
Additional relevant MeSH terms:
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Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers