The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin (FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection (CDI). This study will also compare CDI clinical response to the microbiological response in terms of magnitude of reduction of C. difficile total viable count and spore count during treatment with FDX and if achieved; the time to microbial eradication; determine time to negative CDI toxin assay in stool specimens during treatment with FDX; assess the stool concentrations of FDX and metabolite OP-1118 throughout therapy; assess the length of hospital stay, readmissions and resource utilization for IBD patients receiving FDX; record the incidence and severity of Adverse Events (AEs) and document the impact of treatment on Quality of Life as measured by the changes in Short Inflammatory Bowel Disease Questionnaire (IBDQ) score.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
oral
Site AT43001
Graz, Austria
Site FR33002
Clichy, France
Site FR33001
Paris, France
Site GR30004
Athens, Greece
Site IT39003
Padova, Italy
Site IT39001
Roma, Italy
Site PL48002
Warsaw, Poland
Site PL48003
Warsaw, Poland
Site RU70003
Moscow, Russia
Site RU70002
Moscow, Russia
...and 2 more locations
Pharmacokinetic parameter of fidaxomicin: Maximum plasma concentration (Cmax)
Time frame: Day 1, Day 5 and Day 10
Pharmacokinetic parameter of OP-1118: Maximum plasma concentration (Cmax)
Time frame: Day 1, Day 5 and Day 10
Pharmacokinetic parameter of fidaxomicin: Area under the curve from 0 to 12 hrs (AUC12)
Time frame: Day 1
Pharmacokinetic parameter of OP-1118: Area under the curve from 0 to 12 hrs (AUC12)
Time frame: Day 1
Pharmacokinetic parameter of fidaxomicin and OP-1118: Metabolite to Parent Ratio (MPR)
Time frame: Day 1
Pharmacokinetic parameter of fidaxomicin: Area under the concentration-time curve from the time of dosing to the start of the next dosing interval (AUCtau)
Time frame: Day 5 and Day 10
Pharmacokinetic parameter of OP-1118: Area under the concentration-time curve from the time of dosing to the start of the next dosing interval (AUCtau)
Time frame: Day 5 and Day 10
Pharmacokinetic parameter of fidaxomicin: The time after dosing when Cmax occurs (tmax)
Time frame: Day 1, Day 5 and Day 10
Pharmacokinetic parameter of OP-1118: The time after dosing when Cmax occurs (tmax)
Time frame: Day 1, Day 5 and Day 10
Pharmacokinetic parameter of fidaxomicin: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F)
Time frame: Day 5 and Day 10
Pharmacokinetic parameter of OP-1118: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F)
Time frame: Day 5 and Day 10
Pharmacokinetic parameter of fidaxomicin: Concentration immediately prior to dosing at multiple dosing (Ctrough)
Time frame: Day 5 and Day 10
Pharmacokinetic parameter of OP-1118: Concentration immediately prior to dosing at multiple dosing (Ctrough)
Time frame: Day 5 and Day 10
CDI clinical response
Time frame: Day 12
Microbiological response of C. difficile total viable count, spore count, microbiological eradication and negative CDI toxin assay
Time frame: Day 5 and Day 10
Stool concentrations of fidaxomicin and its metabolite OP-1118
Time frame: Day 1, Day 5 and Day 10
Length of hospital stay, readmissions and resource utilization
Time frame: up to Day 180
Safety as assessed by incidence and severity of adverse events
Time frame: up to Day 180
Health related quality of life as assessed by short IBDQ score
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: Day 10, Day 26, Day 40, Day 90 and Day 180
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