Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004428
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Phase I Randomized Study of CPX for the Treatment of Adult Patients With Mild Cystic Fibrosis
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SCICLONE-FDA-OP-97-1 | None | None | None |