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Review of the Fialuridine (FIAU) Clinical Trials (1995) / Chapter Skim
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Eli Lilly Trial H3X-MC-PPPG
Pages 70-72

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From page 70...
... All three are Lilly employees; the first is a clinical research physician assigned to the Lilly Laboratory for Clinical Research, the second is a mathematician assigned to the Statistical and Mathematical Sciences Division at Lilly Corporate Center, and the third is head of the Bioavailability and Pharmacokinetics Department and the Clinical Analytical Group at the Lilly Laboratory for Clinical Research. HysIop, a ~ 978 graduate of Indiana University School of Medicine, is board certified in internal medicine (1981)
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From page 71...
... Decreases in sperm production and heart muscle damage "in animals given 3,500 to 14,000 times the dose planned for this study" were also reported, and subjects were warned that FTAU or the procedures used in the study might have other unknown effects. An extensive battery of hematology, blood and urine chemistry, and microscopic clinical laboratory tests was conducted 24 hours after the administration of each dose, but no explicit provision for grading toxicity or discontinuing subjects in the study was included in the protocol.
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From page 72...
... ~ ~ ~ 7 ———=— — —— _ _~¢ _ more 1mporlam~y, newer subject warn elevated liver enzyme levels had any clinical signs or symptoms. Although the elevations in serum AST and ALT levels occurred after administration of the second dose of FlAU in 2 of the 17 subjects, a drug hypersensitivity reaction caused by intermittent dosing is not likely to be the explanation, since despite receiving three additional intermittent doses, AST and ALT levels in one subject continued to gradually return to baseline levels.
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Key Terms

  • enzyme levels
  • lilly laboratory
  • indiana university
  • clinical trials
  • neither subject

  • liver enzyme
  • baseline levels
  • level rose
  • acute medical
  • newly developed

  • sensitive analytical
  • serum alt
  • elevated liver
  • liquid chromatography
  • alt level

  • pppc investigators
  • frequently unemployed
  • initial elevation
  • explicit provision
  • lilly employees

  • sufficient grounds
  • miniscule compared
  • grading toxicity
  • intermittent dosing
  • clinical analytical

  • healthy subjects
  • drug hypersensitivity
  • blood count
  • medical treatment
  • included diarrhea


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