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

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ClinicalTrials.gov Identifier: NCT02437591
Recruitment Status : Completed
First Posted : May 7, 2015
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease (IBD) Clostridium Difficile Infection (CDI) Drug: fidaxomicin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)
Actual Study Start Date : August 13, 2015
Actual Primary Completion Date : May 12, 2016
Actual Study Completion Date : October 24, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Fidaxomicin

Arms and Interventions
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Arm Intervention/treatment
Experimental: fidaxomicin
tablet twice daily
 Drug: fidaxomicin
oral
Other Names:
  • PAR-101
  • OPT-80
  • Dificlir
  • ASP2819


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetic parameter of fidaxomicin: Maximum plasma concentration (Cmax) [ Time Frame: Day 1, Day 5 and Day 10 ]
  2. Pharmacokinetic parameter of OP-1118: Maximum plasma concentration (Cmax) [ Time Frame: Day 1, Day 5 and Day 10 ]
  3. Pharmacokinetic parameter of fidaxomicin: Area under the curve from 0 to 12 hrs (AUC12) [ Time Frame: Day 1 ]
  4. Pharmacokinetic parameter of OP-1118: Area under the curve from 0 to 12 hrs (AUC12) [ Time Frame: Day 1 ]
  5. Pharmacokinetic parameter of fidaxomicin and OP-1118: Metabolite to Parent Ratio (MPR) [ Time Frame: Day 1 ]
  6. 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 ]
  7. 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 ]
  8. Pharmacokinetic parameter of fidaxomicin: The time after dosing when Cmax occurs (tmax) [ Time Frame: Day 1, Day 5 and Day 10 ]
  9. Pharmacokinetic parameter of OP-1118: The time after dosing when Cmax occurs (tmax) [ Time Frame: Day 1, Day 5 and Day 10 ]
  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 ]
  11. 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 ]
  12. Pharmacokinetic parameter of fidaxomicin: Concentration immediately prior to dosing at multiple dosing (Ctrough) [ Time Frame: Day 5 and Day 10 ]
  13. Pharmacokinetic parameter of OP-1118: Concentration immediately prior to dosing at multiple dosing (Ctrough) [ Time Frame: Day 5 and Day 10 ]

Secondary Outcome Measures :
  1. CDI clinical response [ Time Frame: Day 12 ]
  2. Microbiological response of C. difficile total viable count, spore count, microbiological eradication and negative CDI toxin assay [ Time Frame: Day 5 and Day 10 ]
  3. Stool concentrations of fidaxomicin and its metabolite OP-1118 [ Time Frame: Day 1, Day 5 and Day 10 ]
  4. Length of hospital stay, readmissions and resource utilization [ Time Frame: up to Day 180 ]
  5. Safety as assessed by incidence and severity of adverse events [ Time Frame: up to Day 180 ]
  6. Health related quality of life as assessed by short IBDQ score [ Time Frame: Day 10, Day 26, Day 40, Day 90 and Day 180 ]
    Inflammatory Bowel Disease Questionnaire (IBDQ)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Male partner agrees not to donate sperm starting at screening and throughout the investigational period.

Exclusion Criteria:

  • Subject has received more than one day of dosing of any CDI therapy within the 48 hrs prior to enrollment
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437591


Locations
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Austria
Site AT43001
Graz, Austria, 8036
France
Site FR33002
Clichy, France, 92110
Site FR33001
Paris, France, 75012
Greece
Site GR30004
Athens, Greece, 11527
Italy
Site IT39003
Padova, Italy, 35128
Site IT39001
Roma, Italy
Poland
Site PL48003
Warsaw, Poland, 02-781
Site PL48002
Warszawa, Poland, 02-507
Russian Federation
Site RU70003
Moscow, Russian Federation, 119435
Site RU70002
Moscow, Russian Federation, 129110
Site RU70001
Saint Petersburg, Russian Federation, 196247
United Kingdom
Site GB44002
London, United Kingdom, E11 1NR
Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Investigators
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Study Director: Medical Monitor Astellas Pharma Europe Ltd.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Astellas Pharma Europe Ltd.
ClinicalTrials.gov Identifier: NCT02437591    
Other Study ID Numbers: 2819-MA-1003
2014-003002-32 ( EudraCT Number )
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe Ltd. ):
ASP2819
PAR-101
OPT-80
Inflammatory Bowel Disease (IBD)
 Clostridium difficile Infection (CDI)
fidaxomicin
Dificlir
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Clostridium Infections
Enterocolitis, Pseudomembranous
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Gastroenteritis
Gram-Positive Bacterial Infections
Bacterial Infections
Enterocolitis
Fidaxomicin
Anti-Bacterial Agents
Anti-Infective Agents