NCT00377741

A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis.

Relative Bioavailability Study of Ganciclovir From the Pro-drug, Valganciclovir, in Lung Transplant Recipients With or Without Cystic Fibrosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the relative bioavailability of ganciclovir from the pro-drug valganciclovir in lung transplant recipients with or without cystic fibrosis. Each patient will receive 900mg valganciclovir daily for the period specified at their center, starting as soon as possible after the transplant. Pharmacokinetic assessments will be made provided that steady-state kinetics of ganciclovir and immunosuppressive drugs have been obtained (\>=4 days of drug therapy). Blood samples for pharmacokinetic analysis will be taken up to 24h post-dose on one occasion. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Conditions

• Cytomegalovirus Infections

Interventions

Type	Name	Description
DRUG	valganciclovir [Valcyte]	900mg po

Timeline

• Start date: 2004-12-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2006-09-18
• Last updated: 2015-12-31
• Results posted: 2015-12-31

Locations

5 sites across 1 country: United States