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NCT02275936 · ClinicalTrials.gov registry record · Phase 1

Study of N91115 in Patients With Cystic Fibrosis Homozygous F508del-CFTR Mutation

A Phase 1 study, sponsored by Nivalis Therapeutics.

Completed
Registry status
Phase 1
Development phase
51
Enrollment target

NCT02275936 is a Phase 1 study that has completed, run by Nivalis Therapeutics. The registered enrollment target is 51 participants.

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The verdict

NCT02275936, a Phase 1 study, has completed, sponsored by Nivalis Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
51 participants
Enrollment target

Study Summary

This Phase 1b study in F508del-CFTR homozygous CF patients is being conducted to assess the safety of N91115 as the sole cystic fibrosis transmembrane conductance regulator (CFTR) modulator at doses near the expected therapeutic exposure level in preparation for Phase 2 studies of N91115 added to the CFTR modulator combination lumacaftor/ivacaftor when launched.

Interventions

  • DRUG N91115

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2015-02
Est. Completion 2015-07
Phase Phase 1

Sponsor

Nivalis Therapeutics

10 total trials

What the Registry Record Tells You About NCT02275936

The ClinicalTrials.gov registry entry for NCT02275936 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nivalis Therapeutics, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which N91115 is the first listed.

NCT02275936 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02275936 about?

NCT02275936 is a clinical study titled "Study of N91115 in Patients With Cystic Fibrosis Homozygous F508del-CFTR Mutation". This Phase 1b study in F508del-CFTR homozygous CF patients is being conducted to assess the safety of N91115 as the sole cystic fibrosis transmembrane conductance regulator (CFTR) modulator at doses near the expected therapeutic exposure level in preparation for Phase 2 studies of N91115 added to th...

What is the current status of trial NCT02275936?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2015-02. Estimated completion is 2015-07.

What interventions are being tested in trial NCT02275936?

The interventions under investigation include: N91115 (DRUG).

Who is sponsoring clinical trial NCT02275936?

This trial is sponsored by Nivalis Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.