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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-23

Study Completion Date

2014-01-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Fungal Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Posaconazole - CF Participants

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 participant is unable to meet the conditions for optimal absorption of posaconazole.

Group Type EXPERIMENTAL

Posaconazole

Intervention Type DRUG

Calogen®

Intervention Type DRUG

Posaconazole - Non-CF Participants

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 participant is unable to meet the conditions for optimal absorption of posaconazole.

Group Type EXPERIMENTAL

Posaconazole

Intervention Type DRUG

Calogen®

Intervention Type DRUG

Interventions

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Posaconazole

Intervention Type DRUG

Calogen®

Intervention Type DRUG

Other Intervention Names

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SCH056592 MK-5592 Noxafil®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No