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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 4

Conditions: Fungal Infection

Treatments: Drug: Posaconazole; Drug: Calogen®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01667107

5592-105

2012-003140-68 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Posaconazole - CF Participants

Experimental group

Description:

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.

Treatment:

Drug: Calogen®

Drug: Posaconazole

Posaconazole - Non-CF Participants

Experimental group

Description:

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.

Treatment:

Drug: Calogen®

Drug: Posaconazole