NCT01748838

Phase 1 Study Assessing the Safety and Tolerability of CTX-4430

A Phase I Randomised, Double-Blind, Placebo-Controlled, Ascending Single & Repeat-Dose Study of Safety, Tolerability & Pharmacokinetics of CTX-4430 When Administered Orally to Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Celtaxsys, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pulmonary Inflammation

Interventions

Type	Name	Description
DRUG	CTX-4430	Ascending single oral doses of CTX-4430 will be administered to subjects in 6 cohorts on day 1. Following a 14-day washout, subjects in two of the six cohorts will cross-over, fed a high fat diet and administered different single oral doses of CTX-4430
OTHER	Mannitol	excipient blended with CTX-4430 in capsules
DRUG	Placebo	Single oral doses of placebo will be administered to subjects in 6 cohorts on day 1. Following a 14-day washout, subjects in two of the six cohorts will cross over, fed a high fat diet and administered single oral doses of placebo
DRUG	CTX-4430	Ascending repeat doses of CTX-4430 will be administered orally, once-daily, to subjects in 4 cohorts on days 1-14.
DRUG	Placebo	Repeat doses of placebo will be administered orally, once-daily, to subjects in 4 cohorts on days 1-14.
OTHER	Mannitol	excipient blended with CTX-4430

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-07-01
• Completion: 2013-09-01
• First posted: 2012-12-13
• Last updated: 2013-09-10

Locations

1 site across 1 country: Australia