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An Open-label, Non-randomized, Phase I Study to Evaluate the Effect of Copanlisib (a Single Intravenous Dose of 60 mg) on the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Metformin (MATE2-K Substrate) in Healthy Volunteers

Trial Profile

An Open-label, Non-randomized, Phase I Study to Evaluate the Effect of Copanlisib (a Single Intravenous Dose of 60 mg) on the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Metformin (MATE2-K Substrate) in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Nov 2021

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At a glance

  • Drugs Copanlisib (Primary) ; Metformin (Primary)
  • Indications Breast cancer; Cholangiocarcinoma; Chronic lymphocytic leukaemia; Colorectal cancer; Diffuse large B cell lymphoma; Endometrial cancer; Follicular lymphoma; Lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma; Non-Hodgkin's lymphoma; Peripheral T-cell lymphoma; Solid tumours; Squamous cell cancer; Urogenital cancer
  • Focus Pharmacokinetics
  • Sponsors Bayer

Most Recent Events

  • 21 Mar 2020 Results presented at the 121st Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
  • 22 Feb 2019 Status changed from active, no longer recruiting to completed.
  • 05 Feb 2019 Planned End Date changed from 18 Jan 2019 to 11 Feb 2019.

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