Phase 3 pharmacokinetics and safety study of a posaconazole tablet formulation in patients at risk for invasive fungal disease

Author:

Cornely Oliver A.1,Duarte Rafael F.2,Haider Shariq3,Chandrasekar Pranatharthi4,Helfgott David5,Jiménez Javier López6,Candoni Anna7,Raad Issam8,Laverdiere Michel9,Langston Amelia10,Kartsonis Nicholas11,Van Iersel Marlou12,Connelly Nancy13,Waskin Hetty13

Affiliation:

1. Department I of Internal Medicine, ZKS Köln, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Cologne, Germany

2. Department of Haematology, Catalan Institute of Oncology, Barcelona, Spain

3. Juravinski Hospital, Hamilton, Ontario, Canada

4. Barbara Ann Karmanos Cancer Institute, Detroit, MI, USA

5. Weill Cornell Medical College, New York, NY, USA

6. Hospital Ramon y Cajal, Madrid, Spain

7. University of Udine, Udine, Italy

8. Department of Stem Cell Transplantation & Cellular Therapy, MD Anderson Cancer Center, Houston, TX, USA

9. Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada

10. Emory University, Atlanta, GA, USA

11. MSD, North Wales, PA, USA

12. MSD, Oss, Netherlands

13. Merck & Co., Inc., Kenilworth, NJ, USA

Abstract

This Phase 1B study showed that a single tablet of 300 mg of posaconazole, given once daily as prophylaxis to 210 patients at risk for invasive fungal disease, was as safe as that reported for posaconazole oral suspension and achieved steady-state >500 ng/mL for all but one patient.

Funder

NIH

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology,Microbiology (medical)

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