PK Study of N91115 in Cystic Fibrosis Patients
Completed · Phase 1
Conditions studied: Cystic Fibrosis
In brief
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.
Key facts
- Study ID
- NCT02227888
- Run by
- Nivalis Therapeutics, Inc.
- People needed
- 6
- Starts
- 2014-10-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2016-11-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- University of Alabama @ Birmingham — Birmingham, Alabama, United States
- Children's CO — Aurora, Colorado, United States
- National Jewish Health — Denver, Colorado, United States
Full record on ClinicalTrials.gov
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