Safety and pharmacokinetics of higher doses of caspofungin in healthy adult participants

Journal of Clinical Pharmacology

Volumn 51, Issue 2, 2011, Pages 202-211

  Migoya, Elizabeth M ^a   Mistry, Goutam C ^a   Stone, Julie A ^a   Comisar, Wendy ^a   Sun, Peng ^a   Norcross, Alisha ^a   Bi, Sheng ^a   Winchell, Gregory A ^a   Ghosh, Kalyan ^a,b   Uemera, Naoto ^a   Deutsch, Paul J ^a,c   Wagner, John A ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b Vislation Inc   (United States)

^c SANOFI   (France)

Author keywords

caspofungin; high dose; pharmacokinetics; safety; tolerability

Indexed keywords

ALANINE AMINOTRANSFERASE; CASPOFUNGIN; PLACEBO;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; CELL INFILTRATION; CONSTIPATION; DIARRHEA; DIZZINESS; DOSAGE SCHEDULE COMPARISON; DOSE RESPONSE; DOSE TIME EFFECT RELATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRY THROAT; ECCHYMOSIS; EPISTAXIS; ERYTHEMA; FLATULENCE; HEADACHE; HUMAN; HUMAN EXPERIMENT; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE RASH; INJECTION SITE SWELLING; MUSCLE TWITCH; NECK PAIN; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; RASH; SIDE EFFECT; SINGLE DRUG DOSE; STEADY STATE; TONSIL DISEASE; VOMITING;

ADOLESCENT; ADULT; ANTIFUNGAL AGENTS; AREA UNDER CURVE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; ECHINOCANDINS; FEMALE; HALF-LIFE; HUMANS; MALE; MIDDLE AGED; YOUNG ADULT;

EID: 79551698090     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270010374853     Document Type: Article

References (17)

1. Ernst EJ, Klepser ME, Ernst ME, Messer SA, Pfaller MA In vitro pharmacodynamic properties of MK-0991 determined by time-kill methods. Diagn Microbiol Infect Dis. 1999 ; 33: 75-80.
2. Antachopoulos C., Meletiadis J., Sein T., Roilides E., Walsh TJ Concentration-dependent effects of caspofungin on the metabolic activity of Aspergillus species. Antimicrob Agents Chemother. 2007 ; 51: 881-887.
3. Abruzzo GK, Gill CJ, Flattery AM, et al. Efficacy of the echinocandin caspofungin against disseminated aspergillosis and candidiasis in cyclophosphamide-induced immunosuppressed mice. Antimicrob Agents Chemother. 2000 ; 44: 2310-2318.
4. Lewis RE, Albert ND, Kontoyiannis DP Comparison of the dose-dependent activity and paradoxical effect of caspofungin and micafungin in a neutropenic murine model of invasive pulmonary aspergillosis. J Antimicrob Chemother. 2008 ; 61: 1140-1144.
5. Villaneuva A., Gotuzzo E., Arathoon EG, et al. A randomized double-blind study of caspofungin versus fluconazole for the treatment of esophageal candidiasis. Am J Med. 2002 ; 113: 294-299.
6. Mora-Duarte J., Betts R., Rotstein C., et al. Comparison of caspofungin and amphotericin B for invasive candidiasis. N Engl J Med. 2002 ; 347: 2020-2029.
7. Cornely OA, Lasso M., Betts R., et al. Caspofungin for the treatment of less common forms of invasive candidiasis. J Antimicrob Chemother. 2007 ; 60: 363-369.
8. Walsh TJ, Teppler H., Donowitz GR, et al. Caspofungin versus liposomal amphotericin B for empirical antifngal therapy in patients with persistent fever and neutropenia. N Engl J Med. 2004 ; 351: 1391-1402.
9. Maertens J., Raad I., Petrikkos G., et al. Efficacy and safety of caspofungin for treatment of invasive aspergillosis in patients refractory to or intolerant of conventional antifungal therapy. Clin Infect Dis. 2004 ; 39: 1563-1571.
10. CANCIDAS (caspofungin acetate) for injection [prescribing information]. Whitehouse Station, NJ: Merck & Co, Inc ; 2005. http://www.merck.com/ product/usa/pi-circulars/c/cancidas/cancidas-pi.pdf
11. Safdar A., Rodriguez G., Rolston KVI, et al. High-dose caspofungin combination antifungal therapy in patients with hematologic malignancies and hematopoietic stem cell transplantation. Bone Marrow Transpl. 2007 ; 39: 157-164.
12. Schwartz M., Kline W., Matuszewski B. Determination of a cyclic hexapeptide (L-743872), a novel pneumocandin antifungal agent in human plasma and urine by high-performance liquid chromatography with fluorescence detection. Analytica Chemica Acta. 1997 ; 352: 299-307.
13. Stone JA, Holland SD, Wickersham PJ, et al. Single- and multiple-dose pharmacokinetics of caspofungin in healthy men. Antimicrob Agents Chemother. 2002 ; 46: 739-745.
14. Stone JA, Migoya EM, Hickey L., et al. Potential for drug interactions between caspofungin and nelfinavir or rifampin. Antimicrob Agents Chemother. 2004 ; 48: 4306-4314.
15. Sable CA, Nguyen B. -YT, Chodakewitz JA, DiNubile MJ Safety and tolerability of caspofungin acetate in the treatment of fungal infections. Transpl Infect Dis. 2002 ; 4: 25-30.
16. Stone JA, Xu X., Winchell GA, et al. Disposition of caspofungin: role of distribution in determining pharmacokinetics in plasma. Antimicrob Agents Chemother. 2004 ; 48: 815-823.
17. Betts R., Nucci M., Talwar D., et al. A multicenter, double-blind trial of a high-dose caspofungin treatment regimen versus a standard caspofungin treatment regimen for adult patients with invasive candidiasis. Clin Infect Dis. 2009 ; 48: 1676-1684.