Nivalis Therapeutics, Inc.

🇺🇸United States

Country: 🇺🇸United States

Ownership: Private, Subsidiary

Established: 2007-01-01

Employees: 1

Market Cap: -

Website: http://www.nivalis.com

Clinical Trials

MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Cavosonstat (N91115) in Healthy Subjects (SNO-9)

Phase 1

Completed

Conditions: Cystic Fibrosis

Interventions: Other: Placebo
Drug: Cavosonstat

First Posted Date: 2016-10-14

Last Posted Date: 2017-01-31

Lead Sponsor: Nivalis Therapeutics, Inc.

Target Recruit Count: 32

Registration Number: NCT02934139

Locations: 🇺🇸
DaVita Clinical Research, Lakewood, Colorado, United States

Study of Cavosonstat (N91115) in CF Patients Who Are Heterozygous for F508del-CFTR and a Gating Mutation and Being Treated With Ivacaftor

Phase 2

Conditions: Cystic Fibrosis

Interventions: Drug: Placebo
Drug: Cavosonstat

First Posted Date: 2016-03-31

Last Posted Date: 2016-11-21

Lead Sponsor: Nivalis Therapeutics, Inc.

Target Recruit Count: 19

Registration Number: NCT02724527

Locations: 🇺🇸
Rainbow Babies and Children's Hospital - Case Medical Center, Cleveland, Ohio, United States
🇺🇸
Nationwide Children's Hospital, Columbus, Ohio, United States
🇺🇸
Johns Hopkins Hospital, Baltimore, Maryland, United States

and more 9 locations

Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation

Phase 2

Completed

Conditions: Cystic Fibrosis

Interventions: Drug: Cavosonstat
Drug: Placebo

First Posted Date: 2015-10-28

Last Posted Date: 2017-01-10

Lead Sponsor: Nivalis Therapeutics, Inc.

Target Recruit Count: 138

Registration Number: NCT02589236

Locations: 🇺🇸
Yale University, New Haven, Connecticut, United States
🇺🇸
Maine Medical Center, Portland, Maine, United States
🇺🇸
Johns Hopkins Hospital, Baltimore, Maryland, United States

and more 43 locations

A Drug-Drug Interaction Study of N91115 +/- Rifampin in Healthy Adult Subjects

Phase 1

Completed

Conditions: Drug Interaction Potentiation

Interventions: Drug: N91115
Drug: Rifampin

First Posted Date: 2015-07-16

Last Posted Date: 2016-11-06

Lead Sponsor: Nivalis Therapeutics, Inc.

Target Recruit Count: 15

Registration Number: NCT02500667

Locations: 🇺🇸
St. Anthony's Medical Plaza 1, Lakewood, Colorado, United States

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

Phase 1

Completed

Conditions: Cystic Fibrosis

Interventions: Drug: N91115

First Posted Date: 2014-10-27

Last Posted Date: 2016-11-06

Lead Sponsor: Nivalis Therapeutics, Inc.

Target Recruit Count: 51

Registration Number: NCT02275936

Locations: 🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸
University of North Carolina, Chapel Hill, North Carolina, United States
🇺🇸
University of Iowa Children's Hospital, Iowa City, Iowa, United States

and more 16 locations

PK Study of N91115 in Cystic Fibrosis Patients

Phase 1

Completed

Conditions: Cystic Fibrosis

Interventions: Drug: N91115

First Posted Date: 2014-08-28

Last Posted Date: 2016-11-06

Lead Sponsor: Nivalis Therapeutics, Inc.

Target Recruit Count: 6

Registration Number: NCT02227888

Locations: 🇺🇸
University of Alabama @ Birmingham, Birmingham, Alabama, United States
🇺🇸
Children's CO, Aurora, Colorado, United States
🇺🇸
National Jewish Health, Denver, Colorado, United States

MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: N91115
Drug: Placebo
Drug: Placebo-Day 1 only

First Posted Date: 2013-12-17

Last Posted Date: 2016-12-21

Lead Sponsor: Nivalis Therapeutics, Inc.

Target Recruit Count: 49

Registration Number: NCT02013388

Locations: 🇺🇸
DaVita Clinical Research, Lakewood, Colorado, United States

Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation

Phase 1

Completed

Conditions: Cystic Fibrosis

Interventions: Drug: N6022
Drug: Normal saline

First Posted Date: 2012-12-11

Last Posted Date: 2014-11-24

Lead Sponsor: Nivalis Therapeutics, Inc.

Target Recruit Count: 66

Registration Number: NCT01746784

Locations: 🇺🇸
Boston Children's Hospital, Boston, Massachusetts, United States
🇺🇸
Cincinnati Children's Hospital, Cincinnati, Ohio, United States
🇺🇸
Rainbow Babies and Children's Hospital - Case Medical Center, Cleveland, Ohio, United States

and more 14 locations

A Safety Study Evaluating N6022 in Multiple-Ascending Doses in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: 20mg/N6022
Drug: 10mg/N6022
Drug: 5 mg/N6022
Drug: Placebo

First Posted Date: 2011-04-21

Last Posted Date: 2015-01-19

Lead Sponsor: Nivalis Therapeutics, Inc.

Target Recruit Count: 25

Registration Number: NCT01339897

Locations: 🇺🇸
Parexel International, Baltimore, Maryland, United States

Study to Evaluate the Bronchoprotective Effects of a Single Dose of N6022 in Patients With Mild Asthma

Phase 1

Completed

Conditions: Asthma

Interventions: Drug: Active
Drug: Placebo

First Posted Date: 2011-03-16

Last Posted Date: 2014-05-05

Lead Sponsor: Nivalis Therapeutics, Inc.

Target Recruit Count: 14

Registration Number: NCT01316315

Locations: 🇺🇸
National Jewish Health, Denver, Colorado, United States
🇺🇸
Duke Asthma, Allergy and Airway Center, Durham, North Carolina, United States

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