Value through Innovation27 July 2016

Clinical Study Results

  • BI 671800 - Healthy
    Clinical Study Number 1268.56
    Study Indication Healthy
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of different salt forms and formulations of single doses either 50 or 200 mg BI 671800 in the fasted or fed state. An open-label, randomised, Phase I study with a 3-period crossover followed by two treatment periods in fixed sequence in healthy male and female volunteers

    Study Document Trial synopsis 1268.56_CO english
  • BI 671800 - Healthy
    Clinical Study Number 1268.59
    Study Indication Healthy
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, safety and tolerability of BI 671800 HEA given200 mg b.i.d. or 400 mg b.i.d. over 7 days. A randomised, doubleblind, placebo controlled within dose groups Phase I study in healthy male and female volunteers

    Study Document Trial synopsis 1268.59 english
  • BI 671800 - Healthy
    Clinical Study Number 1268.60
    Study Indication Healthy
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of single doses of 200 mg BI 671800 HEA administered orally as a delayed release (enteric coated) tablet; or via the EnterionTM capsule as solution to the jejunum, ascending colon or descending colon; or via the EnterionTM capsule as particulate to the ascending colon. An open-label, five periods, fixed sequence phase I study in healthy male volunteers

    Study Document Trial synopsis 1268.60_CO english
  • BI 671800 - Healthy
    Clinical Study Number 1268.7
    Study Indication Healthy
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase I
    Study Title

    A phase I trial to investigate the metabolism and pharmacokinetics ofan open-label single dose of 400 mg [14C] BI 671800 HEA administered as an oral solution of the choline salt in healthy male volunteers

    Study Document Trial synopsis 1268.7_CO english
  • BI 671800 - Healthy
    Clinical Study Number 1268.15
    Study Indication Healthy
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind (within dose groups), parallel group, placebocontrolledphase I study to evaluate the safety, tolerability and pharmacokineticsof single rising doses (50 mg, 200 mg, 400 mg) of BI 671800 HEA in Chinesehealthy male volunteers and multiple rising doses (50 mg b.i.d., 200 mg b.i.d.,400 mg b.i.d.) of BI 671800 HEA in Japanese healthy male volunteers

    Study Document Trial synopsis 1268.15 english
  • BI 671800 - Asthma
    Clinical Study Number 1268.16
    Study Indication Asthma
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase IIa
    Study Title

    Randomised, double-blind, double-dummy, placebo-controlled, parallel group study to assess the efficacy and safety of 6 weeks of oral BI 671800 ED 400 mg b.i.d., Montelukast 10 mg q.d., or placebo in symptomatic asthma patients on fluticasone propionate MDI

    Study Document Trial synopsis 1268.16 english
  • BI 671800 - Rhinitis, Allergic, Perennial
    Clinical Study Number 1268.41
    Study Indication Rhinitis, Allergic, Perennial
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase IIa
    Study Title

    Randomised, double-blind, triple-dummy, partial crossover (each active treatment with placebo) study using an Environmental Challenge Chamber(ECC) to assess the safety and efficacy of 2 weeks of oral BI 671800 ED 50, 200or 400 mg b.i.d., compared to montelukast 10 mg q.d., fluticasone propionatenasal spray 200 µg q.d. (2 nasal actuations to each nostril of 50 µg) versus placebo in seasonal allergic rhinitis patients out-of-season, sensitive to Dactylisglomerata

    Study Document Trial synopsis 1268.41 english
  • BI 671800 - Asthma
    Clinical Study Number 1268.53
    Study Indication Asthma
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase IIa
    Study Title

    A randomised, double-blind, placebo-controlled, efficacy and safety cross-over study of 4 weeks of oral BI 671800 ED 200 mg twice daily or 400 mg once daily administered in the morning (AM) or evening (PM), in symptomatic asthma patients on inhaled fluticasone propionate MDI

    Study Document Trial synopsis 1268.53_DR english
  • BI 671800 - Asthma
    Clinical Study Number 1268.17
    Study Indication Asthma
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase IIa
    Study Title

    A randomized, double blind, placebo and active controlled, parallel group study to evaluate the safety and efficacy of 6-week treatment with oral doses of 50 mg b.i.d., 200 mg b.i.d., and 400 mg b.i.d. BI 671800 ED in steroid-naive patients with persistent asthma

    Study Document Trial synopsis 1268.17_DR english
  • BI 671800 - Healthy
    Clinical Study Number 1268.4
    Study Indication Healthy
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of different salt forms and different extended release formulations of single doses of either 50 or 200 mg BI 671800 in the fasted or fed state. An open-label, randomised, Phase I study with a 5-way crossover followed by two treatment periods in fixed sequence in healthy male and female volunteers

    Study Document Trial statement 1268.4_DR english

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