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Completed Phase 1 Interventional

PK Study of N91115 in Cystic Fibrosis Patients

ClinicalTrials.gov ID: NCT02227888

Public ClinicalTrials.gov record NCT02227888. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 4:01 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1, Open-Label Study Evaluating the Pharmacokinetics of N91115 in Cystic Fibrosis Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02227888
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Nivalis Therapeutics, Inc.
Industry
Enrollment
6 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2014
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014
Last update posted
Nov 6, 2016

2014 – 2015

United States locations

U.S. sites
3
U.S. states
2
U.S. cities
3
Facility City State ZIP Site status
University of Alabama @ Birmingham Birmingham Alabama 35294
Children's CO Aurora Colorado 80045
National Jewish Health Denver Colorado 80206

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02227888, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 6, 2016 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02227888 live on ClinicalTrials.gov.

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