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

NCT02500667 | Completed Phase 1 DMC

• 1 other identifier: N91115-1H-04 (SNO-5)
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Interaction Potentiation

Keywords

N91115; Rifampin; drug interaction; Cavosonstat

Outcome Measures

Primary Outcomes (1)

• Assess the Potential Effects of Rifampin on N91115 Steady State Area Under the Curve (AUC) Values

  To assess the effects of multiple oral dose administration of rifampin on the steady state AUC on Day 14 of N91115 in healthy subjects.

  On Study Day 14

Secondary Outcomes (3)

• Effects of Rifampin on the AUC vs time of Metabolites of N91115

  On Study Day 14

• The number of participants with adverse events

  Over the 21 days of the study

• Effects of Rifampin on N91115 and its Metabolites on Urine 12 Hour drug concentrations

  Day 14 assessment

Study Arms (1)

N91115 + Rifampin

EXPERIMENTAL

N91115 200 mg twice daily (BID) from Study Day 1- 13, Rifampin 600 mg once daily (QD) from Study Day 8 - 12

Drug: N91115; Drug: Rifampin

Interventions

N91115 DRUG

200 mg BID

Also known as: Cavosonstat

N91115 + Rifampin

Rifampin DRUG

600 mg QD

Also known as: Rifadin

N91115 + Rifampin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Nivalis Therapeutics, Inc.: lead
• Davita Clinical Research: collaborator

Study Sites (1)

St. Anthony's Medical Plaza 1

Lakewood, Colorado, 80228, United States

Location

Related Publications (1)

• Donaldson SH, Solomon GM, Zeitlin PL, Flume PA, Casey A, McCoy K, Zemanick ET, Mandagere A, Troha JM, Shoemaker SA, Chmiel JF, Taylor-Cousar JL. Pharmacokinetics and safety of cavosonstat (N91115) in healthy and cystic fibrosis adults homozygous for F508DEL-CFTR. J Cyst Fibros. 2017 May;16(3):371-379. doi: 10.1016/j.jcf.2017.01.009. Epub 2017 Feb 13.

  PMID: 28209466 DERIVED

MeSH Terms

Interventions

cavosonstat; Rifampin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Christopher Galloway, MD

  Davita Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: July 16, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 7, 2016

Record last verified: 2016-11

Locations

US (1)