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Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Investigate Safety, Tolerability and Pharmacokinetics of Increasing Multiple Oral Doses of BAY2328065 Including the CYP3A4 Induction Potential of BAY2328065 and Randomized Cross-over Investigation of the Relative Bioavailability Between Solution and Tablet Formulation in Healthy Male Participants

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Trial Profile

Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Investigate Safety, Tolerability and Pharmacokinetics of Increasing Multiple Oral Doses of BAY2328065 Including the CYP3A4 Induction Potential of BAY2328065 and Randomized Cross-over Investigation of the Relative Bioavailability Between Solution and Tablet Formulation in Healthy Male Participants

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Nov 2021

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At a glance

  • Drugs BAY-2328065 (Primary) ; BAY-2328065 (Primary) ; Midazolam
  • Indications Endometriosis
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Bayer

Most Recent Events

  • 20 Nov 2020 Status changed from active, no longer recruiting to completed.
  • 17 Sep 2020 Status changed from recruiting to active, no longer recruiting.
  • 20 Aug 2020 Time frame changed from Up to 30 days after end of treatment to From first dosing up to 30 days after end of treatment with study intervention, summing up to approximately 39 to 45 days for a participant for safety endpoints.

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