Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-01-04 @ 6:47 AM
Study NCT ID:
NCT02708992
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2016-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cefixime / Azithromycin pK Study
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
The Pharmacokinetics of Extended Duration High-Dose Cefixime Co-administered With Azithromycin for the Decreased Susceptibility of Neisseria Gonorrhoeae: A Phase I Pilot Study
Status:
COMPLETED
Status Verified Date:
2017-07-19
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:
This is a PK study of a multi-dose oral cefixime regimen (three 800 mg doses given on a q 8-hour schedule) alone and also co administered with a single 1000 mg oral dose of azithromycin, both within a 24-hour period, in order to achieve total serum cefixime levels of mcg/mL for at least 20 hours. This will determine the tolerability of the regimen and whether there are significant changes in cefixime PK after co-administration. The primary pharmacokinetic objectives are: to determine if a cefixime dosing regimen of three 800 mg doses given alone, on a q 8-hour schedule achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; to determine if a cefixime dosing regimen of three 800 mg doses given on a q 8 hour schedule co-administered with a single 1000 mg of azithromycin, achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; and to evaluate whether a single 1000 mg dose of azithromycin alters the PK of a three dose regimen of 800
Detailed Description:
This is a PK study of a multi-dose oral cefixime regimen (three 800 mg doses given on a q 8-hour schedule) alone and also co administered with a single 1000 mg oral dose of azithromycin, both within a 24-hour period, in order to achieve total serum cefixime levels of mcg/mL for at least 20 hours. This will determine the tolerability of the regimen and whether there are significant changes in cefixime PK after co-administration. The primary pharmacokinetic objectives are: to determine if a cefixime dosing regimen of three 800 mg doses given alone, on a q 8-hour schedule achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; to determine if a cefixime dosing regimen of three 800 mg doses given on a q 8 hour schedule co-administered with a single 1000 mg of azithromycin, achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; and to evaluate whether a single 1000 mg dose of azithromycin alters the PK of a three dose regimen of 800 mg cefixime given on a q 8-hour schedule. The primary safety objectives are to assess the safety and tolerability of a treatment regimen that includes three doses of 800 mg cefixime; to assess the safety and tolerability of a treatment regimen that includes three doses of 800 mg cefixime co-administered with a single 1000 mg dose of azithromycin. The study will take place for 10 weeks.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HHSN272201500006I | None | None | View |