Status:
COMPLETED
PK Study of N91115 in Cystic Fibrosis Patients
Lead Sponsor:
Nivalis Therapeutics, Inc.
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ini...
Detailed Description
This is an open-label pharmacokinetic (PK) study of twice daily doses of 50 mg of N91115 administered for 14 days in F508del-CFTR homozygous CF patients. Six patients are planned for enrollment. Each ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02227888
Start Date
October 1 2014
End Date
January 1 2015
Last Update
November 7 2016
Active Locations (3)
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1
University of Alabama @ Birmingham
Birmingham, Alabama, United States, 35294
2
Children's CO
Aurora, Colorado, United States, 80045
3
National Jewish Health
Denver, Colorado, United States, 80206