Research Site
Stockholm, Sweden
NCT Number: NCT01789528
The purpose of this study is to investigate the effect of administration of CAZ-AVI and CXL on the intestinal flora of male and female healthy volunteers after multiple administrations over 7 days. An assessment of the effect on intestinal flora is an important aspect to understand for the safe clinical use of the investigational products and is expected by regulatory agencies.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Stockholm, Sweden
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Females: Female healthy volunteers are authorised to participate in this study if both of the following criteria are met:
Exclusion criteria
IV infusion
Other names: Cohort 1
IV infusion
Other names: Cohort 2
Time frame: Change from baseline (Day-1) at Day 2, 5, 7, 10, 14 and 21
The number and types of microorganisms in faeces.
Time frame: Screening up to 12 days after discharge from study site
Adverse event, ECG, safety laboratory assessments, physical examinations and vital signs.
Time frame: Days 1, 2 and 5: Pre-dose and 2 hours post dose. Day 7: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 12, and 24 hours post dose (Day 8)
On Day 7, the following pharmacokinetic parameters will be calculated when applicable:
Maximum plasma concentration (Cmax), time of Cmax (tmax), time of last quantifiable plasma concentration (last), area under the plasma concentration-time curve during the dosing interval (AUC(0-τ)), area under the plasma concentration time curve from zero to the time of the last quantifiable concentration (AUC(0-t)), half-life (t½), systemic plasma clearance (CL), apparent plasma clearance (CL/F), volume of distribution at steady state (Vss), and apparent volume of distribution (Vz/F).
Time frame: Days 1, 2 and 5: Pre-dose and 1 hour post dose. Day 7: pre-dose, 0.5, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 5, 7, 8, 12, and 24 hours post dose (Day 8)
On Day 7, the following pharmacokinetic parameters will be calculated when applicable:
Maximum plasma concentration (Cmax), time of Cmax (tmax), time of last quantifiable plasma concentration (last), area under the plasma concentration-time curve during the dosing interval (AUC(0-τ)), area under the plasma concentration time curve from zero to the time of the last quantifiable concentration (AUC(0-t)), half-life (t½), systemic plasma clearance (CL), apparent plasma clearance (CL/F), volume of distribution at steady state (Vss), and apparent volume of distribution (Vz/F).
Time frame: Day -1, 2, 5, 7, 10, 14 and 21
The concentrations of CAZ-AVI and CXL will be determined in plasma and faecal samples.
Time frame: Day -1, 2, 5, 7, 10, 14 and 21
Minimal inhibitory concentration (MIC) for CAZ-AVI and CXL will be determined for new colonizing bacteria from faecal samples.
Pfizer
Industry
A Phase 1, Open-label, Multiple-dose, Single Centre Study to Investigate the Effect of Administration of CAZ-AVI and CXL on the Intestinal Flora of Healthy Volunteers.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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