A Study to Look at the Way the Body Absorbs and Distributes Posaconazole in the Blood and Lungs of Lung Transplant Recipients (PAPAL Study)

Conditions: Invasive fungal infection (IFI) in lung transplant patients with and without cystic fibrosis.
MedDRA version: 15.0Level: PTClassification code 10049085Term: Antifungal prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2012-003140-68-GB

Lead Sponsor: MSD

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

1.Each patient must be willing and able to provide, and give, written informed consent for the trial. 2.Each patient must be scheduled to undergo lung transplantation. 3.Each patient must be = 18 years of age and may be of either sex or any race/ethnicity. 4.Each patient must be able to adhere to dose and visit schedules. 5.Each patient must be able to take oral/nasogastric medication. 6. Patients undertake not to become pregnant during the study. Women of childbearing potential, male study participants and the sexual partners of men participating in this study must use an effective method of birth control while taking part in this study and for a period of six weeks after completion of the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 39
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

1.Hypersensitivity/previous reaction to posaconazole and related compounds, 2.Severe liver disease (Child –Pugh classification C), 3.Current use of ergot alkaloids or hydroxymethyl-coenzyme A (HMG-CoA) reductase inhibitors (simvastatin, lovastatin and atorvastatin) within 7 days prior to transplant. Pravastatin is permitted, 4.Current use of CYP3A4 inhibitors including terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine within 7 days prior to transplant, 5.Treatment with posaconazole within 14 days prior to transplant, 6.The patient or a family member is among the investigational or sponsor staff directly involved with this trial.