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Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses and Multiple Oral Doses of BI 1323495 Versus Placebo in Healthy Male Japanese Subjects Genotyped as Poor and Extensive Metabolizers of UGT2B17 (Single-blind, Randomised, Placebo-controlled [Within Dose Groups] Trial), Including an Investigation of Drug-drug Interaction With Itraconazole in Healthy Male Subjects Genotyped as Poor Metabolizers of UGT2B17 (an Open-label, Two-period, Fixed Sequence Trial)

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Trial Profile

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses and Multiple Oral Doses of BI 1323495 Versus Placebo in Healthy Male Japanese Subjects Genotyped as Poor and Extensive Metabolizers of UGT2B17 (Single-blind, Randomised, Placebo-controlled [Within Dose Groups] Trial), Including an Investigation of Drug-drug Interaction With Itraconazole in Healthy Male Subjects Genotyped as Poor Metabolizers of UGT2B17 (an Open-label, Two-period, Fixed Sequence Trial)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 29 Mar 2024

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At a glance

  • Drugs BI 1323495 (Primary) ; Itraconazole
  • Indications Chronic obstructive pulmonary disease
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Boehringer Ingelheim
  • Most Recent Events

    • 10 Aug 2021 Status changed from active, no longer recruiting to completed.
    • 19 Jul 2021 Status changed from recruiting to active, no longer recruiting.
    • 06 Apr 2021 Planned number of patients changed from 50 to 74.
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