Title
Phase I Randomized Study of CPX for the Treatment of Adult Patients With Mild Cystic Fibrosis
Phase
Phase 1Lead Sponsor
Food and Drug AdministrationStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Cystic FibrosisIntervention/Treatment
cpx ...Study Participants
35OBJECTIVES: 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.
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.
PROTOCOL ENTRY CRITERIA: Mild cystic fibrosis Not pregnant or nursing Negative pregnancy test
