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Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 685509 Over 28 Days in Patients With Mild and Moderate Hepatic Impairment and of Single Oral BI 685509 Dose Compared to Healthy Volunteers

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Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 685509 Over 28 Days in Patients With Mild and Moderate Hepatic Impairment and of Single Oral BI 685509 Dose Compared to Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 13 Jan 2022

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At a glance

  • Drugs Avenciguat (Primary)
  • Indications Diabetic nephropathies; Renal failure
  • Focus Adverse reactions
  • Sponsors Boehringer Ingelheim

    • Most Recent Events

    • 15 Nov 2021 Results of sub-group analysis (n=23) assessing HepQuant SHUNT test measures effective sinusoidal perfusion as a result of the flow-dependent hepatic clearance of cholate (CA) from the systemic and portal circulations, presented at The Liver Meeting 2021: 72nd Annual Meeting of the American Association for the Study of Liver Diseases.
    • 15 Nov 2021 Results assessing the safety, pharmacokinetics (PK) and efficacy of BI 685509 in patients with mild and moderate hepatic impairment presented at The Liver Meeting 2021: 72nd Annual Meeting of the American Association for the Study of Liver Diseases
    • 08 Jun 2021 Status changed from recruiting to completed.

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