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Completed

NCT Number: NCT02437591

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

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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Key information

Conditions

Inflammatory Bowel Disease (IBD) Bacterial Infections Bacterial Infections and Mycoses Clostridium Difficile Infection (CDI) Clostridium Infections Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Gram-Positive Bacterial Infections Infections Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Site AT43001, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fidaxomicin

Drug

oral

Other names: PAR-101, OPT-80, Dificlir, ASP2819

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe Ltd.

Industry

Registry information

Official study title

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

Acronym: PROFILE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 7, 2015
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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