Trial reportClinical pharmacology in drug development2022
Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Isavuconazonium Sulfate in Healthy Adult Japanese Subjects.
Trial report in Clinical pharmacology in drug development, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.
- Efficacy and safety of isavuconazole for invasive fungal infections: A systematic review and meta-analysis of randomized controlled trials.Medical mycology · 2025Pooled it
- Clinical research advances of isavuconazole in the treatment of invasive fungal diseases.Frontiers in cellular and infection microbiology · 2022Pooled it
- Exploratory model-based optimizing isavuconazole dosing regimens forFrontiers in cellular and infection microbiology · 2026Article
- Prospective study of pharmacokinetics of isavuconazole in critically ill patients undergoing continuous hemodialysis with and without acute-on-chronic liver failure.Annals of intensive care · 2026Article
- Pharmacokinetic study of isavuconazonium in human plasma measured by HPLC-MS/MS and its use in healthy Chinese subjects.Bioanalysis · 2025Article
- Repurposing FDA-Approved Agents to Develop a PrototypePharmaceuticals (Basel, Switzerland) · 2025Article
- Pharmacokinetics of isavuconazole at different target sites in healthy volunteers after single and multiple intravenous infusions.The Journal of antimicrobial chemotherapy · 2024Article
- A Pharmacokinetic Bioequivalence Study Comparing Different-Strength and -Size Capsules of Isavuconazonium Sulfate in Healthy Japanese Subjects.Clinical pharmacology in drug development · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Isavuconazonium sulfate is the water-soluble prodrug of the novel, broad-spectrum, triazole antifungal agent isavuconazole. This was a first-in-Japanese study assessing the pharmacokinetics, safety, and tolerability of isavuconazonium sulfate. The study was conducted in 2 parts: part 1 (single ascending dose; 100-, 200-, and 400-mg equivalent of isavuconazole oral or intravenous administration); and part 2 (multiple doses for 16 days; 200-mg equivalent of isavuconazole oral or intravenous administration; once-daily administration with a loading regimen every 8 hours for the first 48 hours). A total of 60 and 16 subjects were randomized in part 1 and part 2, respectively. Observed clearance was lower in this study compared to what was previously reported in predominantly White populations and similar to clearance in non-Japanese Asian populations. The range of the plasma isavuconazole concentration in this study was within the range of the pivotal phase 3 study, with no relationship between isavuconazole exposure and either efficacy or safety. There were no serious adverse events, and all reported treatment-emergent adverse events were of mild intensity. This study confirmed that isavuconazonium sulfate was safe and well tolerated in healthy adult Japanese subjects.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.