N91115 (DrugBank: -)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 299 | Cystic fibrosis | 5 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02934139 (ClinicalTrials.gov) | October 2016 | 10/10/2016 | MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Cavosonstat (N91115) in Healthy Subjects (SNO-9) | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of N91115 in Healthy Subjects | Cystic Fibrosis | Drug: Cavosonstat;Other: Placebo | Nivalis Therapeutics, Inc. | NULL | Completed | 18 Years | 55 Years | All | 32 | Phase 1 | United States |
| 2 | NCT02724527 (ClinicalTrials.gov) | April 2016 | 11/3/2016 | Study of Cavosonstat (N91115) in CF Patients Who Are Heterozygous for F508del-CFTR and a Gating Mutation and Being Treated With Ivacaftor | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of N91115 for Efficacy and Safety in Patients With CF Heterozygous for F508del-CFTR + Gating Mutation Being Treated With Ivacaftor | Cystic Fibrosis | Drug: Cavosonstat;Drug: Placebo | Nivalis Therapeutics, Inc. | NULL | Active, not recruiting | 18 Years | N/A | Both | 19 | Phase 2 | United States |
| 3 | NCT02589236 (ClinicalTrials.gov) | November 2015 | 26/10/2015 | Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of N91115 to Evaluate Efficacy and Safety in Patients With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation Treated With Lumacaftor/Ivacaftor | Cystic Fibrosis | Drug: Cavosonstat;Drug: Placebo | Nivalis Therapeutics, Inc. | Medidata Solutions | Completed | 18 Years | N/A | All | 138 | Phase 2 | United States |
| 4 | NCT02275936 (ClinicalTrials.gov) | February 2015 | 14/10/2014 | Study of N91115 in Patients With Cystic Fibrosis Homozygous F508del-CFTR Mutation | A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Study of N91115 to Evaluate Safety and Pharmacokinetics in Patients With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: N91115 | Nivalis Therapeutics, Inc. | NULL | Completed | 18 Years | 80 Years | Both | 51 | Phase 1 | United States |
| 5 | NCT02227888 (ClinicalTrials.gov) | October 2014 | 26/8/2014 | PK Study of N91115 in Cystic Fibrosis Patients | A Phase 1, Open-Label Study Evaluating the Pharmacokinetics of N91115 in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: N91115 | Nivalis Therapeutics, Inc. | NULL | Completed | 18 Years | N/A | Both | 6 | Phase 1 | United States |