A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105) (PAPAL)

This study has been terminated.
(Study terminated due to an unfavorable risk-benefit analysis)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01667107
First received: August 14, 2012
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

This single site study will examine plasma and alveolar compartment (AC) levels of posaconazole in cystic fibrosis (CF) and non-cystic fibrosis (non-CF) lung transplant recipients receiving routine post-operative anti-fungal prophylaxis. Invasive fungal infection rates will be assessed following transplantation.


Condition Intervention Phase
Fungal Infection
Drug: Posaconazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pharmacokinetic Analysis of Posaconazole in the Plasma and Alveolar Compartment of Lung Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Time to reach steady state plasma concentration of posaconazole [ Time Frame: Through Day 12 ] [ Designated as safety issue: No ]
  • Concentrations of posaconazole in plasma and alveolar compartment (AC) [ Time Frame: Through Day 41 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of participants who develop invasive fungal infection [ Time Frame: Through Week 12 post transplant ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: January 2013
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Posaconazole - CF Participants
Posaconazole will be administered to approximately 20 lung transplant participants with CF.
Drug: Posaconazole
Posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the patient is unable to meet the conditions for optimal absorption of posaconazole.
Other Names:
  • SCH056592
  • MK-5592
  • Noxafil®
Experimental: Posaconazole - Non-CF Participants
Posaconazole will be administered to approximately 20 lung transplant participants without CF (non-CF).
Drug: Posaconazole
Posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the patient is unable to meet the conditions for optimal absorption of posaconazole.
Other Names:
  • SCH056592
  • MK-5592
  • Noxafil®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled to undergo lung transplantation
  • Able to take oral/nasogastric medication
  • Females of childbearing potential, males, and the sexual partners of males must use an effective method of birth control during this study and for 6 weeks after completing the study.

Exclusion Criteria:

  • Severe liver disease
  • Current use of cytochrome P-450 (CYP)-3A4 inhibitors including terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine within 7 days before transplant
  • Treatment with posaconazole within 14 days before transplant
  • Breastfeeding
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01667107     History of Changes
Other Study ID Numbers: 5592-105, 2012-003140-68
Study First Received: August 14, 2012
Last Updated: February 11, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Mycoses
Posaconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on April 17, 2014