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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Duke University School of Medicine - Duke Clinical Research Institute - Duke Clinical Research Unit
Durham, North Carolina, United States
AUC from 0 to infinity [AUC0-infinity]
Time frame: Day 1,2,3,10,11,12 and at early termination
Averaged composite plasma cefixime levels will be used to generate PK curves of cefixime levels versus time
Time frame: Day 1,2,3,10,11,12 and at early termination
Elimination half-life (t1/2)
Time frame: Day 1,2,3,10,11,12 and at early termination
Elimination rate (lambda z)
Time frame: Day 1,2,3,10,11,12 and at early termination
Individual plasma cefixime levels will be used to generate PK curves of cefixime levels versus time
Time frame: Day 1,2,3,10,11,12 and at early termination
Peak cefixime level (Cmax)
Time frame: Day 1,2,3,10,11,12 and at early termination
Safety blood test results
Time frame: Day: -28,-1, 2, 3, 9, 11, 12, 17 and at early termination
Safety urinanalysis results
Time frame: Day: -28, -1, 2, 3, 9, 11, 12, 17 and at early termination
Subject reported AEs
Time frame: Day: 1, 2, 3, 9, 10, 11, 12, 17 and at early termination
Subject reported serious adverse events (SAEs)
Time frame: Day: 1, 2, 3, 9, 10, 11, 12, 17 and at early termination
Targeted clinical evaluations
Time frame: Day: -1,1, 2, 3, 9, 10, 11, 12, 17 and at early termination
Time that cefixime levels exceed four times the MIC of 0.5 mcg/mL (i.e., a plasma level of 2.0 mcg/mL)
Time frame: Day 1,2,3,10,11,12 and at early termination
Time to peak drug level (Tmax)
Time frame: Day 1,2,3,10,11,12 and at early termination
Total area under the curve (AUC from 0 hours to the time of next dosing [AUC0-t])
Time frame: Day 1,2,3,10,11,12 and at early termination
Total plasma concentrations of cefixime
Time frame: Day 1,2,3,10,11,12 and at early termination
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