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.
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Pharmacokinetic parameter of fidaxomicin: Maximum plasma concentration (Cmax)
Timeframe: Day 1, Day 5 and Day 10
Pharmacokinetic parameter of OP-1118: Maximum plasma concentration (Cmax)
Timeframe: Day 1, Day 5 and Day 10
Pharmacokinetic parameter of fidaxomicin: Area under the curve from 0 to 12 hrs (AUC12)
Timeframe: Day 1
Pharmacokinetic parameter of OP-1118: Area under the curve from 0 to 12 hrs (AUC12)
Timeframe: Day 1
Pharmacokinetic parameter of fidaxomicin and OP-1118: Metabolite to Parent Ratio (MPR)
Timeframe: 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)
Timeframe: 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)
Timeframe: Day 5 and Day 10
Pharmacokinetic parameter of fidaxomicin: The time after dosing when Cmax occurs (tmax)
Timeframe: Day 1, Day 5 and Day 10
Pharmacokinetic parameter of OP-1118: The time after dosing when Cmax occurs (tmax)
Timeframe: Day 1, Day 5 and Day 10
Pharmacokinetic parameter of fidaxomicin: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F)
Timeframe: Day 5 and Day 10
Pharmacokinetic parameter of OP-1118: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F)
Timeframe: Day 5 and Day 10
Pharmacokinetic parameter of fidaxomicin: Concentration immediately prior to dosing at multiple dosing (Ctrough)
Timeframe: Day 5 and Day 10
Pharmacokinetic parameter of OP-1118: Concentration immediately prior to dosing at multiple dosing (Ctrough)
Timeframe: Day 5 and Day 10