We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01419678
Recruitment Status : Completed
First Posted : August 18, 2011
Last Update Posted : December 8, 2014
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Pittsburgh

Brief Summary:
This is a single center, observational study of posaconazole PK sampling in lung transplant recipients. The patients enrolled will have up to 6 (3ml) pk samples (a total of 18 ml) and one 10ml blood sample for a total collection of 28ml of blood obtained over the entire study. In addition, the investigators will collect medical record information and any excess BAL samples available during the study (tests done as part of the patient's clinical care and the samples would have been discarded once diagnosis was made).

Condition or disease Intervention/treatment
Lung Transplant Infection Fungal Infection Other: collection of blood samples for PK testing

Detailed Description:
PK blood samples will be obtained around a clinical dosing of posaconazole

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients
Study Start Date : October 2011
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 'collection of blood samples for PK testing'
collection of PK samples around a dosing of Posaconazole
Other: collection of blood samples for PK testing
PK samples collected around dosing of posaconazole

Primary Outcome Measures :
  1. measure the levels of posaconazole post dosing [ Time Frame: 24 hours after dosing ]
    pk samples will be obtained around dosing of medication and then analyzed for posaconazole levels

Secondary Outcome Measures :
  1. determine the posaconazole concentration within the pulmonary epithelial lining fluid (ELF) and alveolar cells [ Time Frame: 1 year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • 18 years of age and older receiving posaconazole post transplant as part of their care received a lung transplant

Exclusion Criteria:

  • must meet inclusion criteria

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): NCT01419678

United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Merck Sharp & Dohme Corp.
Principal Investigator: Ryan Shields, Pharm D University of Pittsburgh

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01419678     History of Changes
Other Study ID Numbers: PRO10110232
First Posted: August 18, 2011    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014

Keywords provided by University of Pittsburgh:
PK blood sampling

Additional relevant MeSH terms:
Communicable Diseases
Antifungal Agents
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs