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Phase 1b study of new posaconazole tablet for prevention of invasive fungal infections in high-risk patients with neutropenia.

Publication ,  Journal Article
Duarte, RF; López-Jiménez, J; Cornely, OA; Laverdiere, M; Helfgott, D; Haider, S; Chandrasekar, P; Langston, A; Perfect, J; Ma, L; Connelly, N ...
Published in: Antimicrob Agents Chemother
October 2014

Posaconazole tablets, a new oral formulation of posaconazole, can be effective when given as antifungal prophylaxis to neutropenic patients at high risk for invasive fungal infection (e.g., those with acute myelogenous leukemia or myelodysplastic syndrome). Such effectiveness might be specifically important to patients with poor oral intake because of nausea, vomiting, or chemotherapy-associated mucositis. This was a prospective, global study in high-risk patients to characterize the pharmacokinetics and safety profile of posaconazole tablets and to identify the dose of posaconazole tablets that would provide exposure within a predefined range of exposures (steady-state average concentration [area under the concentration-time curve/24 h] of ≥500 ng/ml and ≤2,500 ng/ml in >90% of patients). The study evaluated two sequential dosing cohorts: 200 mg posaconazole once daily (n = 20) and 300 mg posaconazole once daily (n = 34) (both cohorts had a twice-daily loading dose on day 1) taken without regard to food intake during the neutropenic period for ≤28 days. The exposure target was reached (day 8) in 15 of 19 (79%) pharmacokinetic-evaluable patients taking 200 mg posaconazole once daily and in 31 of 32 (97%) patients taking 300 mg posaconazole once daily; 300 mg posaconazole once daily achieved the desired exposure target. Posaconazole tablets were generally well tolerated in high-risk neutropenic patients. (This study has been registered at ClinicalTrials.gov under registration no. NCT01777763.).

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Published In

Antimicrob Agents Chemother

DOI

EISSN

1098-6596

Publication Date

October 2014

Volume

58

Issue

10

Start / End Page

5758 / 5765

Location

United States

Related Subject Headings

  • Triazoles
  • Tablets
  • Neutropenia
  • Mycoses
  • Middle Aged
  • Microbiology
  • Male
  • Humans
  • Female
  • Antifungal Agents
 

Citation

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Duarte, R. F., López-Jiménez, J., Cornely, O. A., Laverdiere, M., Helfgott, D., Haider, S., … Waskin, H. (2014). Phase 1b study of new posaconazole tablet for prevention of invasive fungal infections in high-risk patients with neutropenia. Antimicrob Agents Chemother, 58(10), 5758–5765. https://doi.org/10.1128/AAC.03050-14
Duarte, Rafael F., Javier López-Jiménez, Oliver A. Cornely, Michel Laverdiere, David Helfgott, Shariq Haider, Pranatharthi Chandrasekar, et al. “Phase 1b study of new posaconazole tablet for prevention of invasive fungal infections in high-risk patients with neutropenia.Antimicrob Agents Chemother 58, no. 10 (October 2014): 5758–65. https://doi.org/10.1128/AAC.03050-14.
Duarte RF, López-Jiménez J, Cornely OA, Laverdiere M, Helfgott D, Haider S, et al. Phase 1b study of new posaconazole tablet for prevention of invasive fungal infections in high-risk patients with neutropenia. Antimicrob Agents Chemother. 2014 Oct;58(10):5758–65.
Duarte, Rafael F., et al. “Phase 1b study of new posaconazole tablet for prevention of invasive fungal infections in high-risk patients with neutropenia.Antimicrob Agents Chemother, vol. 58, no. 10, Oct. 2014, pp. 5758–65. Pubmed, doi:10.1128/AAC.03050-14.
Duarte RF, López-Jiménez J, Cornely OA, Laverdiere M, Helfgott D, Haider S, Chandrasekar P, Langston A, Perfect J, Ma L, van Iersel MLPS, Connelly N, Kartsonis N, Waskin H. Phase 1b study of new posaconazole tablet for prevention of invasive fungal infections in high-risk patients with neutropenia. Antimicrob Agents Chemother. 2014 Oct;58(10):5758–5765.

Published In

Antimicrob Agents Chemother

DOI

EISSN

1098-6596

Publication Date

October 2014

Volume

58

Issue

10

Start / End Page

5758 / 5765

Location

United States

Related Subject Headings

  • Triazoles
  • Tablets
  • Neutropenia
  • Mycoses
  • Middle Aged
  • Microbiology
  • Male
  • Humans
  • Female
  • Antifungal Agents