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First-In-Human Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Study of G1T28-1 in Healthy Male and Female Subjects

Trial Profile

First-In-Human Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Study of G1T28-1 in Healthy Male and Female Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 29 Apr 2019

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At a glance

  • Drugs Trilaciclib (Primary)
  • Indications Cancer; Myelosuppression
  • Focus Adverse reactions; First in man
  • Sponsors G1 Therapeutics
  • Most Recent Events

    • 29 Apr 2019 According to the G1 Therapeutics media release, company plans to submit Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and expect to file NDA in the U.S. in 2020, based on the data from this study.
    • 09 Aug 2017 Phase 1 and preclinical data for trilaciclib published in Science Translational Medicine, according to G1 Therapeutics financial report.
    • 29 Jun 2015 Status changed from recruiting to completed, according to ClinicalTrials.gov record.
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