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@ARTICLE{Kutzsche:874644,
      author       = {Kutzsche, Janine and Jürgens, Dagmar and Willuweit, Antje
                      and Adermann, Knut and Fuchs, Carola and Simons, Stefanie
                      and Windisch, Manfred and Hümpel, Michael and Rossberg,
                      Wolfgang and Wolzt, Michael and Willbold, Dieter},
      title        = {{S}afety and pharmacokinetics of the orally available
                      antiprionic compound {PRI}‐002: {A} single and multiple
                      ascending dose phase {I} study},
      journal      = {Alzheimer's $\&$ dementia / Translational research $\&$
                      clinical interventions Translational research $\&$ clinical
                      interventions [...]},
      volume       = {6},
      number       = {1},
      issn         = {2352-8737},
      address      = {Amsterdam [u.a.]},
      publisher    = {Elsevier},
      reportid     = {FZJ-2020-01563},
      pages        = {e12001},
      year         = {2020},
      abstract     = {IntroductionPRI‐002 is an orally available anti–amyloid
                      beta (Aβ) prionic compound developed for direct disassembly
                      of toxic Aβ oligomers relevant to Alzheimer's
                      disease.MethodsTwo placebo‐controlled clinical phase I
                      trials with oral dosing of PRI‐002 were conducted in
                      healthy young subjects: A single ascending dose trial (4,
                      12, 36, 108, or 320 mg PRI‐002 or placebo) in 40
                      participants followed by a multiple ascending dose study
                      with daily 160 mg PRI‐002 for 14 days or 320 mg for 28
                      days in 24 participants. The main objectives were safety,
                      tolerability, and evaluation of pharmacokinetic (PK)
                      parameters.ResultsPRI‐002 was safe and well tolerated
                      after single and multiple oral administration up to the
                      highest doses. PRI‐002 was absorbed rapidly and drug
                      exposure increased proportional to dose. During repeated
                      daily administration, the drug accumulated by a factor of
                      about three. Steady‐state conditions were reached after 1
                      to 2 weeks.ConclusionsThe safety and PK results encourage
                      further clinical development of PRI‐002.},
      cin          = {IBI-7 / INM-4},
      ddc          = {610},
      cid          = {I:(DE-Juel1)IBI-7-20200312 / I:(DE-Juel1)INM-4-20090406},
      pnm          = {553 - Physical Basis of Diseases (POF3-553)},
      pid          = {G:(DE-HGF)POF3-553},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:32211506},
      UT           = {WOS:000751652300062},
      doi          = {10.1002/trc2.12001},
      url          = {https://juser.fz-juelich.de/record/874644},
}