Universität zu Köln

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:	Creators Email ORCID ORCID Put Code Maertens, Johan UNSPECIFIED UNSPECIFIED UNSPECIFIED Cornely, Oliver A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ullmann, Andrew J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Heinz, Werner J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Krishna, Gopal UNSPECIFIED UNSPECIFIED UNSPECIFIED Patino, Hernando UNSPECIFIED UNSPECIFIED UNSPECIFIED Caceres, Maria UNSPECIFIED UNSPECIFIED UNSPECIFIED Kartsonis, Nicholas UNSPECIFIED UNSPECIFIED UNSPECIFIED Waskin, Hetty UNSPECIFIED UNSPECIFIED UNSPECIFIED Robertson, Michael N. UNSPECIFIED UNSPECIFIED UNSPECIFIED
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:	Keywords Language EXPOSURE-RESPONSE RELATIONSHIP; VERSUS-HOST-DISEASE; ORAL POSACONAZOLE; PROPHYLAXIS; FLUCONAZOLE; INFECTIONS; ITRACONAZOLE; FORMULATIONS; PLASMA Multiple languages Microbiology; Pharmacology & Pharmacy Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/43513