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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: October 6, 2014
Last verified: October 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: January 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 6, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Mycoses
Posaconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Trypanocidal Agents

ClinicalTrials.gov processed this record on November 25, 2014