Clinical Trial: Cefixime / Azithromycin pK Study

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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 S

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 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 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.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome:

• 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&nbs
  
  

  Original Primary Outcome:

  • Total serum concentrations of cefixime [ Time Frame: Day 1,2,3,10,11,12 and at early termination ]
  • AUC from 0 to infinity [AUC0-infinity] [ Time Frame: Day 1,2,3,10,11,12 and at early termination ]
  • Averaged composite serum 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 ]
  • 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 ]
  • Time to peak drug level (Tmax) [ 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 ]
  • Time that cefixime levels exceed four times the MIC of 0.5 mcg/mL (i.e., a serum level of 2.0 mcg/mL) [ 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 ]
  • Targeted clinical evaluations [ Time Frame: Day: -1,1, 2, 3, 9, 10, 11, 12, 17 and at earl
    
    

    Current Secondary Outcome:
    
    

    Original Secondary Outcome:
    
    Information By: National Institute of Allergy and Infectious Diseases (NIAID)
    

    Dates:
    Date Received: March 10, 2016
    Date Started: April 28, 2016
    Date Completion: July 31, 2017
    Last Updated: April 20, 2017
    Last Verified: December 7, 2016