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Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Inflammatory Bowel Disease (IBD); Clostridium Difficile Infection (CDI)

Intervention: fidaxomicin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Astellas Pharma Europe Ltd.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Astellas Pharma Europe Ltd.

Overall contact:
Medical Affairs Europe, Phone: +44(0)20 3379 8000, Email: Astellas.registration@astellas.com


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.

Clinical Details

Official title: Open Label Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Pharmacokinetic parameter of fidaxomicin: Maximum plasma concentration (Cmax)

Pharmacokinetic parameter of fidaxomicin: Area under the curve from 0 to 12 hrs (AUC12)

Pharmacokinetic parameter of fidaxomicin: Area under the concentration-time curve from the time of dosing to the start of the next dosing interval (AUCtau)

Pharmacokinetic parameter of fidaxomicin: The time after dosing when Cmax occurs (tmax)

Pharmacokinetic parameter of fidaxomicin: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F)

Pharmacokinetic parameter of fidaxomicin: Concentration immediately prior to dosing at multiple dosing (Ctrough)

Secondary outcome:

CDI clinical response

Microbiological response of C. difficile total viable count, spore count and negative CDI toxin assay

Stool concentrations of fidaxomicin and its metabolite OP-1118

Length of hospital stay, readmissions and resource utilization

Safety as assessed by incidence and severity of adverse events

Health related quality of life as assessed by short IBDQ score


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

- Harvey-Bradshaw Index (HBI) (Crohn's disease subjects) of 5 or more

- 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 is taking or requiring to be treated with prohibited medications. Exception

being, in the case of any CDI therapy: a Subject is allowed to have received a maximum of one day of dosing within the last 48 hrs of any CDI therapy

- 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

Locations and Contacts

Medical Affairs Europe, Phone: +44(0)20 3379 8000, Email: Astellas.registration@astellas.com

Asklepios Westklinikum Hamburg, Hamburg, Germany; Recruiting

General Hospital of Athens EVAGGELISMOS, Athens, Greece; Recruiting

Laiko General Hospital, University of Athens, Athens, Greece; Recruiting

Additional Information

Starting date: June 2015
Last updated: July 8, 2015

Page last updated: August 20, 2015

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