Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 425809 Tablets Given Orally Once Daily for 12 Days to Young and Elderly Healthy Male and Female Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Study)(Part 1) and Comparison of Pharmacokinetics of a Single Oral Dose of BI 425809 After Oral Administration in the Morning Versus Oral Administration in the Evening in Young Healthy Male and Female Volunteers (Randomised, Two-sequence, Open, Two Period, Two-way Cross Over) (Part 2)

Trial Profile

Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 425809 Tablets Given Orally Once Daily for 12 Days to Young and Elderly Healthy Male and Female Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Study)(Part 1) and Comparison of Pharmacokinetics of a Single Oral Dose of BI 425809 After Oral Administration in the Morning Versus Oral Administration in the Evening in Young Healthy Male and Female Volunteers (Randomised, Two-sequence, Open, Two Period, Two-way Cross Over) (Part 2)

Completed
Phase of Trial: Phase I

Latest Information Update: 21 Mar 2016

At a glance

  • Drugs BI 425809 (Primary)
  • Indications Unspecified
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Boehringer Ingelheim
  • Most Recent Events

    • 19 Nov 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
    • 02 Nov 2015 Status changed from recruiting to active, no longer recruiting as per ClinicalTrials.gov record.
    • 05 Oct 2015 Planned End Date changed from 1 Oct 2015 to 1 Nov 2015, as reported by ClinicalTrials.gov.
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