This trial is active, not recruiting.

Conditions inflammatory bowel disease (ibd), clostridium difficile infection (cdi)
Treatment fidaxomicin
Phase phase 4
Sponsor Astellas Pharma Europe Ltd.
Collaborator Merck Sharp & Dohme Corp.
Start date June 2015
End date May 2016
Trial size 25 participants
Trial identifier NCT02437591, 2014-003002-32, 2819-MA-1003


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; 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
tablet twice daily
fidaxomicin PAR-101

Primary Outcomes

Pharmacokinetic parameter of fidaxomicin: 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 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 fidaxomicin: 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 fidaxomicin: Concentration immediately prior to dosing at multiple dosing (Ctrough)
time frame: Day 5 and Day 10

Secondary Outcomes

CDI clinical response
time frame: Day 12
Microbiological response of C. difficile total viable count, spore count 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
time frame: Day 10, Day 26, Day 40, Day 90 and Day 180

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Confirmed diagnosis or history of IBD for at least 3 months - Subject has have active IBD defined by : - partial MAYO score (ulcerative colitis subjects) of 2 or more, where at least 1 point has to originate from blood in stool - Harvey-Bradshaw Index (HBI) (Crohn's disease subjects) of 5 or more, excluding points for complications - CDI confirmed positive according to local standard testing for the presence of C. difficile within 48 hr prior to enrollment - Female subject is not breastfeeding at Screening or while participating in this study - Subject agrees to practice effective birth control from Screening and while participating in this study - Subject agrees not to participate in another interventional study while participating in this study Exclusion Criteria: - Subject has received more than one day of dosing of any CDI therapy within the 48 hrs prior to enrolment - Subject is unable to swallow oral study medication - Presence of an ostomy or short bowel syndrome - Subject has a current diagnosis of toxic megacolon - Subject is not willing to adhere to the provisions of treatment and observation specified in the protocol - Subject has been enrolled into this study previously, has taken any investigational drug within 28 days or 5 half-lives, whichever is longer, prior to enrollment, or is currently participating in another clinical study which may influence the assessment of efficacy and/or safety endpoints of this study, in the opinion of the Sponsor - Subject has previously participated in a CDI vaccine study - Subject has hypersensitivity to FDX or any of its components - Subject has a condition which, in the Investigator's opinion, makes the Subject unsuitable for study participation

Additional Information

Official title Open Label Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Astellas Pharma Inc.