PK Study of N91115 in Cystic Fibrosis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2016
• Main ID: NCT02227888
• Date of registration: 26/08/2014
• Prospective Registration: Yes
• Primary sponsor: Nivalis Therapeutics, Inc.
• Public title: PK Study of N91115 in Cystic Fibrosis Patients SNO3
• Scientific title: A Phase 1, Open-Label Study Evaluating the Pharmacokinetics of N91115 in Cystic Fibrosis Patients
• Date of first enrolment: October 2014
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02227888
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Steven Shoemaker, MD
• Affiliation: Nivalis Therapeutics, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Confirmed diagnosis of CF, homozygous for the F508del-CFTR mutation

2. Weight = 40 kg at screening

3. FEV1 = 40% of predicted normal for age, gender, and height (Hankinson standards) pre
or post-bronchodilator value, at screening

4. Hematology, clinical chemistry, and urinalysis results with no clinically significant
abnormalities that would interfere with the study assessments at screening

Exclusion Criteria:

1. 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

2. 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

3. 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

4. History, including the screening assessment, of ventricular tachycardia or
ventricular arrhythmias

5. History, including the screening assessment, of prolonged QT and/or QTcF
(Fridericia's correction) interval (> 450 msec)

6. History of solid organ or hematological transplantation

7. History of alcohol abuse or drug addiction (including cannabis, cocaine, and opioids)
in the year prior to screening

8. Use of continuous (24 hr/day) or nocturnal supplemental oxygen



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: N91115

Primary Outcome(s)

Pharmacokinetics [Time Frame: 14 Days]

Secondary Outcome(s)

Safety of dosing twice per day over 14 days [Time Frame: 14 Days]

Secondary ID(s)

N91115-1PK-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors