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Phase I, Open-label, Randomized, Two Part, Three-Period, Two-Sequence, Cross-over Study to Investigate the Relative Bioavailability of a Tablet Formulation Compared to Powder-in-Capsule of M7583 Including a Food Effect Evaluation for the Tablet in Healthy Volunteers

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Trial Profile

Phase I, Open-label, Randomized, Two Part, Three-Period, Two-Sequence, Cross-over Study to Investigate the Relative Bioavailability of a Tablet Formulation Compared to Powder-in-Capsule of M7583 Including a Food Effect Evaluation for the Tablet in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 28 Jul 2023

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At a glance

  • Drugs TL 895 (Primary)
  • Indications B-cell lymphoma
  • Focus Pharmacokinetics
  • Sponsors Merck KGaA
  • Most Recent Events

    • 15 Jun 2023 Results assessing the pharmacokinetics and bruton tyrosine kinase occupancy pharmacodynamics of TL-895 in fasted and fed states, and effect of acid reducingagents on TL-895 PK and PD in fed healthy subjects, presented at the 28th Congress of the European Haematology Association.
    • 15 Jun 2023 Results by deriving data from this and other study developing and validating a mechanistic absorption and pharmacokinetic model of covalent Btk inhibitor Tl- 895 to evaluate the influence of food and acid reducing agents, presented at the 28th Congress of the European Haematology Association
    • 22 Jan 2018 Status changed from active, no longer recruiting to completed.
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