Evidence map›Paper›PMID 27278712›Full record

ArticleClinical pharmacology in drug development2017

Pharmacokinetic and Pharmacodynamic Evaluation of the Drug-Drug Interaction Between Isavuconazole and Warfarin in Healthy Subjects.

Amit Desai, Takao Yamazaki, Albert J Dietz, Donna Kowalski, Christopher Lademacher, Helene Pearlman, Shahzad Akhtar, Robert Townsend

Open access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical pharmacology in drug development, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
3.1field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 28 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Combined Oral Contraceptives As Victims of Drug Interactions.Drug metabolism and disposition: the biological fate of chemicals · 2023
    Review
  5. Article
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  7. Article
  8. Reply to Baud and Houzé, "ShouldAntimicrobial agents and chemotherapy · 2020
    Article
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 3 countries.

Amit DesaiAstellas Pharma Global Development, Inc, Northbrook, IL, USA.
Takao YamazakiAstellas Pharma Global Development, Inc, Northbrook, IL, USA.
Albert J DietzSpaulding Clinical Research, LLC, West Bend, WI, USA.
Donna KowalskiAstellas Pharma Global Development, Inc, Northbrook, IL, USA.
Christopher LademacherAstellas Pharma Global Development, Inc, Northbrook, IL, USA.
Helene PearlmanAstellas Pharma Global Development, Inc, Northbrook, IL, USA.
Shahzad AkhtarAstellas Pharma Global Development, Inc, Northbrook, IL, USA.
Robert TownsendAstellas Pharma Global Development, Inc, Northbrook, IL, USA.
Astellas Pharma (United States) · USAmerican College · CY

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase 1 trial evaluated pharmacokinetic and pharmacodynamic interactions between the novel triazole antifungal agent isavuconazole and warfarin in healthy adults. Multiple doses of isavuconazole were administered as the oral prodrug, isavuconazonium sulfate (372 mg 3 times a day for 2 days loading dose, then 372 mg once daily thereafter; equivalent to isavuconazole 200 mg), in the presence and absence of single doses of oral warfarin sodium 20 mg. Coadministration with isavuconazole increased the mean area under the plasma concentration-time curves from time 0 to infinity of S- and R-warfarin by 11% and 20%, respectively, but decreased the mean maximum plasma concentrations of S- and R-warfarin by 12% and 7%, respectively, relative to warfarin alone. Mean area under the international normalized ratio curve and maximum international normalized ratio were 4% lower in the presence vs absence of isavuconazole. Mean warfarin area under the prothrombin time curve and maximum prothrombin time were 3% lower in the presence vs absence of isavuconazole. There were no serious treatment-emergent adverse events (TEAEs), and no subjects discontinued the study due to TEAEs. All TEAEs were mild in intensity. These findings indicate that coadministration with isavuconazole has no clinically relevant effects on warfarin pharmacokinetics or pharmacodynamics.

Indexed as

AdultArea Under CurveDrug Administration ScheduleDrug InteractionsFemaleHealthy VolunteersHumansInternational Normalized RatioMaleMiddle AgedNitrilesProthrombin TimePyridinesTriazolesWarfarinYoung AdultisavuconazoleNitrilesPyridinesTriazolesWarfarinCYP2C9CYP3A4isavuconazoleisavuconazoniumwarfarin

Identifiers

PMID27278712
PMCPMC5298089
OpenAlexW2409344437

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.