Phase 1 Study Assessing the Safety and Tolerability of CTX-4430
Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to assess the safety and tolerability of CTX-4430 capsules taken
orally once daily in normal healthy volunteers. CTX-4430 is being developed to treat lung
inflammation that occurs in cystic fibrosis (CF). This study includes two-parts: Part 1
assesses single dosing; and Part 2 assesses repeat dosing for 14 days. Each part will include
several dosages. During the single-dose part of the study, following a 14-day washout period,
two cohorts will be assessed for potential effects on tolerability when fed at the time of
dosing. For both parts of the study, blood samples will be collected for PK assay validation.
Phase:
Phase 1
Details
Lead Sponsor:
Celtaxsys, Inc.
Collaborators:
Clinical Network Services CPR Pharma Services Pty Ltd, Australia Linear Clinical Research