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A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105 AM2) (PAPAL)

This study is currently recruiting participants.
Verified March 2013 by Merck
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01667107
First received: August 14, 2012
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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 ]

Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667107

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United Kingdom
Merck Sharp & Dohme Ltd. Recruiting
Hoddesdon, United Kingdom
Contact: Paul Robinson     44 1992452396        
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01667107     History of Changes
Other Study ID Numbers: 5592-105, 2012-003140-68
Study First Received: August 14, 2012
Last Updated: March 22, 2013
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 May 19, 2013