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 N91115-ICF-03 (SNO-4)
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- STATUS
- Not Recruiting
Summary
The purpose of this study is to investigate the safety and tolerability of three different doses of oral N91115 administered twice daily over 28 days in cystic fibrosis patients homozygous for F508del-CFTR in preparation for combination therapy with lumacaftor/ivacaftor when launched.
Description
The purpose of this study is to investigate the safety and tolerability of three different doses of oral N91115 administered twice daily over 28 days in cystic fibrosis patients homozygous for F508del-CFTR in preparation for combination therapy with lumacaftor/ivacaftor when launched.
Details
| Condition | cystic fibrosis |
|---|---|
| Age | 100years or below |
| Clinical Study Identifier | TX4948 |
| Last Modified on | 19 February 2024 |
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