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

• Status: Terminated
• Trial end date: 2014-01-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Posaconazole

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