Value through Innovation27 July 2016

Clinical Study Results

  • BI 653048 - Healthy
    Clinical Study Number 1262.1
    Study Indication Healthy
    Product BI 653048
    Generic Name BI 653048
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of BI 653048 H3PO4 oral drinking solution in healthy male volunteers (dose range: 0.1 mg –1500 mg). A single-blind (within dose groups), randomised, placebo controlled within dose groups, single rising dose Phase I study

    Study Document Trial synopsis 1262.1 english
  • BI 653048 - Healthy
    Clinical Study Number 1262.2
    Study Indication Healthy
    Product BI 653048
    Generic Name BI 653048
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics (biomarkers) of BI 653048 BS H3PO4 capsule formulation administered as multiple doses of 25 mg to 200 mg qd for 10 days. A randomised, double-blind within dose groups, placebo-controlled, multiple rising dose trial with open-label active comparator

    Study Document Trial synopsis 1262.2_CO english
  • BI 653048 - Healthy
    Clinical Study Number 1262.9
    Study Indication Healthy
    Product BI 653048
    Generic Name BI 653048
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacodynamics and pharmacokinetics of a BI 653048 BS H3PO4 capsule formulation administered as multiple doses of 25 mg to 200 mg once daily (qd) for 3 days assessing pharmacodynamics as endotoxin-induced inflammatory response of asingle intravenous bolus administration of 2 ng/kg body weight lipopolysaccharide (LPS). A randomised, double-blind within dose groups, placebo-controlled, multiple rising dose phase I trial with open label active comparator in healthy male subjects

    Study Document Trial synopsis 1262.9_CO english
  • BI 653048 - Healthy
    Clinical Study Number 1267.1
    Study Indication Healthy
    Product BI 653048
    Generic Name BI 653048
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses of 0.25, 0.5, 1, 2, 4, 20, 50, 100, 150 and 200 mg BI 60732 Powder in Bottle (PIB) administered to healthy male volunteers in a randomised, double blind, placebo controlled phase I trial. 

    Study Document Trial synopsis 1267.1_CO english

Clinical Trial Registry and structured study results. Find here protocol information for all clinical study types.

European Trial Register of EU studies.