PK Study of N91115 in Cystic Fibrosis Patients

NCT02227888 | Completed Phase 1

• 1 other identifier: N91115-1PK-02
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

Brief Summary

This Phase 1 study in F508del-CFTR homozygous CF patients is being conducted to assess the pharmacokinetics and absorption dynamics of N91115 compared with healthy subjects in order to identify an initial starting dose for Phase 2 trials.

Conditions

Cystic Fibrosis

Keywords

CF; F508Del; Cavosonstat; N91115

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics

  To assess the pharmacokinetics of N91115 after twice daily (q 12 h) doses given for 14 days by measuring plasma and urine concentrations of N91115 and its primary metabolite.

  14 Days

Secondary Outcomes (1)

• Safety of dosing twice per day over 14 days

  14 Days

Study Arms (1)

N91115

EXPERIMENTAL

Every 12 hour oral dosing of 50 mg N91115 for 14 days

Drug: N91115

Interventions

N91115 DRUG

S nitrosoglutathione reductase inhibitor

Also known as: Cavosonstat

N91115

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of CF, homozygous for the F508del-CFTR mutation
• Weight ≥ 40 kg at screening
• FEV1 ≥ 40% of predicted normal for age, gender, and height (Hankinson standards) pre or post-bronchodilator value, at screening
• Hematology, clinical chemistry, and urinalysis results with no clinically significant abnormalities that would interfere with the study assessments at screening

You may not qualify if:

• History of any illness or condition that in the opinion of the investigator could confound the results of the study or pose additional risk when administered IMP
• Any acute infection, including acute upper or lower respiratory infections and pulmonary exacerbations that require treatment or hospitalizations within 4 weeks of Study Day 1
• Any change in chronic therapies for CF lung disease (e.g., Ibuprofen, Pulmozyme®, hypertonic saline, Azithromycin, TOBI®, Cayston®) within 4 weeks of Study Day 1
• History, including the screening assessment, of ventricular tachycardia or ventricular arrhythmias
• History, including the screening assessment, of prolonged QT and/or QTcF (Fridericia's correction) interval (\> 450 msec)
• History of solid organ or hematological transplantation
• History of alcohol abuse or drug addiction (including cannabis, cocaine, and opioids) in the year prior to screening
• Use of continuous (24 hr/day) or nocturnal supplemental oxygen

Sponsors & Collaborators

• Nivalis Therapeutics, Inc.: lead

Study Sites (3)

University of Alabama @ Birmingham

Birmingham, Alabama, 35294, United States

Location

Children's CO

Aurora, Colorado, 80045, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

cavosonstat

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Steven Shoemaker, MD

  Nivalis Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 28, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: November 7, 2016

Record last verified: 2016-11

Locations

US (3)