Maertens, Johan, Cornely, Oliver A., Ullmann, Andrew J., Heinz, Werner J., Krishna, Gopal, Patino, Hernando, Caceres, Maria, Kartsonis, Nicholas, Waskin, Hetty and Robertson, Michael N. (2014). Phase 1B Study of the Pharmacokinetics and Safety of Posaconazole Intravenous Solution in Patients at Risk for Invasive Fungal Disease. Antimicrob. Agents Chemother., 58 (7). S. 3610 - 3618. WASHINGTON: AMER SOC MICROBIOLOGY. ISSN 1098-6596

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Abstract

This was a phase 1B, dose-ranging, multicenter, pharmacokinetics, and safety study of cyclodextrin-based posaconazole intravenous (i.v.) solution administered through a central line to subjects at high risk for invasive fungal disease (part 1 of a 2-part study [phase 1B/3]). Initially, the safety and tolerability of single-dose posaconazole i.v. 200 mg (n = 10) were compared with those of a placebo (n = 11). Subsequently, 2 doses were evaluated, posaconazole i.v. 200 mg once daily (q.d.) (n = 21) and 300 mg q.d. (n = 24). The subjects received twice-daily (b.i.d.) posaconazole i.v. on day 1, followed by 13 days of posaconazole i.v. q.d., then 14 days of posaconazole oral suspension 400 mg b.i.d. The steady-state (day 14) exposure target (average concentration [areas under concentration-time curve {AUCs}/24 h, average concentrations at steady state {C(avg)s}], of >= 500 to <= 2,500 ng/ml in >= 90% of the subjects) was achieved by 94% of the subjects for 200 mg posaconazole q.d. and by 95% of subjects for 300 mg posaconazole q.d. The desired exposure target (mean steady-state C-avg, similar to 1,200 ng/ml) was 1,180 ng/ml in the 200-mg dosing cohort and was exceeded in the 300-mg dosing cohort (1,430 ng/ml). Posaconazole i.v. was well tolerated. Posaconazole i.v. 300 mg q.d. was selected for the phase 3 study segment.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Maertens, JohanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cornely, Oliver A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ullmann, Andrew J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heinz, Werner J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Krishna, GopalUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Patino, HernandoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Caceres, MariaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kartsonis, NicholasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Waskin, HettyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Robertson, Michael N.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-435135
DOI: 10.1128/AAC.02686-13
Journal or Publication Title: Antimicrob. Agents Chemother.
Volume: 58
Number: 7
Page Range: S. 3610 - 3618
Date: 2014
Publisher: AMER SOC MICROBIOLOGY
Place of Publication: WASHINGTON
ISSN: 1098-6596
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
EXPOSURE-RESPONSE RELATIONSHIP; VERSUS-HOST-DISEASE; ORAL POSACONAZOLE; PROPHYLAXIS; FLUCONAZOLE; INFECTIONS; ITRACONAZOLE; FORMULATIONS; PLASMAMultiple languages
Microbiology; Pharmacology & PharmacyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/43513

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