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PK Study of N91115 in Cystic Fibrosis Patients

NCT02227888 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2016-11-07

No results posted yet for this study

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

Interventions

DRUG

N91115

S nitrosoglutathione reductase inhibitor

Sponsors & Collaborators

  • Nivalis Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Steven Shoemaker, MD · Nivalis Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02227888 on ClinicalTrials.gov