NCT00004428

Phase I Randomized Study of CPX for the Treatment of Adult Patients With Mild Cystic Fibrosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (planned)
• Sponsor: FDA Office of Orphan Products Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Evaluate the safety of ascending doses of CPX administered to adult patients with mild cystic fibrosis. II. Evaluate the pharmacokinetics of ascending doses of CPX in this patient population.

Detailed description

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, dose escalation study. There are 7 experimental cohorts, each treated with a different oral dose of CPX or placebo. Within each cohort, 4 patients receive a single dose of CPX and 1 patient receives placebo. Each patient is monitored 24 hours postdose. Escalation to the next dose level for each subsequent cohort begins only after the safety data obtained from the previous cohort is reviewed and found not to limit dose escalation. All patients return for a follow up evaluation 1 week after dosing.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	CPX

Timeline

• Start date: 1997-09-01
• Completion: 1999-10-01
• First posted: 1999-10-19
• Last updated: 2015-03-25