Value through Innovation27 July 2016

Clinical Study Results

  • Amelubant - Healthy
    Clinical Study Number 543.1
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind, randomised, placebo-controlled, parallel-group study to investigate the safety, tolerability, biological effects and preliminary pharmacokinetics of increasing single oral doses of BIIL 284 BS (dose range: 0.025 mg- 75 mg PSE solution, 25 mg, 75 mg, 250 mg and 750 mg WIF tablets) in healthy male volunteers as well as food effects at 75 mg (WIF tablet).

    Study Document Trial synopsis 543.1 english
  • Amelubant - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 543.10
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase IIa
    Study Title

    Effect of 14-Day Treatment with BIIL 284 BS on Patients with COPD (Double-Blind, Placebo-Controlled, Randomised, Parallel Group Study)

    Study Document Trial synopsis 543.10_CO english
  • Amelubant - Asthma
    Clinical Study Number 543.11
    Study Indication Asthma
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase IIa
    Study Title

    The effect BIIL 284 BS ( 14 day treatment) on induced-sputum variables in patients with bronchial asthma (a double-blind. randomized, placebo-controlled parallel study)

    Study Document Trial synopsis 543.11_CO english
  • Amelubant - Arthritis, Rheumatoid
    Clinical Study Number 543.14
    Study Indication Arthritis, Rheumatoid
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I/IIa
    Study Title

    A double-blind, randomized, three parallel group placebo-controlled study to investigate pharmacokinetics, effect on expression of CD11b/CD18 (Mac-1), as well as safety and efficacy of two oral doses of BIIL 284 BS (dosage: 25 mg daily, 150 mg daily) in patients with rheumatoid arthritis over two weeks.

    Study Document Trial synopsis 543.14 english
  • Amelubant - Healthy
    Clinical Study Number 543.16
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of Metabolism and Pharmacokinetics of [14C] BIIL 284 BS After Administration of a Single Oral Dose of 25 mg [ 14C] BIIL 284 BS in 6 Healthy Volunteers

    Study Document Trial snyopsis 543.16_CO english
  • Amelubant - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 543.17
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase IIa
    Study Title

    Effect of 12-week treatment of 5, 25 or 75 mg BIIL 284 BS on exercise endurance in patients with chronic obstructive pulmonary disease (double-blind, double dummy, placebo-controlled, randomized, parallel group, dose ranging study)

    Study Document Trial synopsis 543.17 english
  • Amelubant - Healthy
    Clinical Study Number 543.24
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    The Effect of Multiple Doses of BIIL 284 BS on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Male Subjects (A randomized, double-blind, placebo-controlled, two period, two-way cross-over study)

    Study Document Trial synopsis 543.24_CO english
  • Amelubant - Hepatic Insufficiency
    Clinical Study Number 543.26
    Study Indication Hepatic Insufficiency
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    The Pharmacokinetics, Safety and Tolerability of Single Dose BIIL 284 BS in Patients with Hepatic Impairment in Comparison to Healthy Volunteers (An Open Label, Matched Pair, One Center Study)

    Study Document Trial synopsis 543.26 english
  • Amelubant - Arthritis, Rheumatoid
    Clinical Study Number 543.27
    Study Indication Arthritis, Rheumatoid
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase IIa
    Study Title

    Three month, randomised, double-blind, double-dummy, placebo controlled, multiple dose-range study of the efficacy and safety of BIIL284 BS (5, 25 and 75 mg p.o. once daily) in adult patients with active Rheumatoid Arthritis

    Study Document Trial synopsis 543.27 english
  • Amelubant - Healthy
    Clinical Study Number 543.28
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    Randomised 4-way cross-over phase I study to investigate the relative bioavailability of BIIL 284 BS 75 mg boli in comparison to tablet C in fasted condition and after ingestion of a standardised meal in healthy volunteers.

    Study Document Trial synopsis 543.28 english
  • Amelubant - Healthy
    Clinical Study Number 543.3
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    Randomised 3-way cross-over phase I study to investigate the relative bioavailability of BIIL 284 BS 75 mg tablet C and tablet D in comparison to WIF tablet in healthy volunteers.

    Study Document Trial synopsis 543.3 english
  • Amelubant - Healthy
    Clinical Study Number 543.31
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    Randomised, open-label, two-way crossover study in male healthy volunteers to investigate the relative bioavailability of BIIL 284 BS 5 mg Tablet FF in comparison to Tablet C after ingestion of a standardised meal.

    Study Document Trial synopsis 543.31_CO english
  • Amelubant - Cystic Fibrosis
    Clinical Study Number 543.36
    Study Indication Cystic Fibrosis
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase Ib
    Study Title

    A randomized, double-blind within dose, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of increasing single oral doses of BIIL 284 BS in adult and pediatric cystic fibrosis patients

    Study Document Trial synopsis 543.36_CO english
  • Amelubant - Cystic Fibrosis
    Clinical Study Number 543.37
    Study Indication Cystic Fibrosis
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase Ib
    Study Title

    A randomized, double-blind within dose, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of repeated oral doses (15-day dosing) of BIIL 284 BS in adult (150 mg) and pediatric (75 mg) cystic fibrosis patients 

    Study Document Trial synopsis 543.37 english
  • Amelubant - Healthy
    Clinical Study Number 543.4
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind, randomised, placebo-controlled, parallel-group study to investigate the safety, tolerability, biological effects and preliminary pharmacokinetics of increasing repeated oral doses (9 days dosing) of BIIL 284 BS (doses: 25 mg, 150 mg, 250 mg as WIF tablets) in healthy male volunteers.

    Study Document Trial synopsis 543.4 english
  • Amelubant - Healthy
    Clinical Study Number 543.5
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    Randomised 3-way cross-over phase I study to investigate the effect of different food compositions (low fat and high fat meal) on bioavailability of BIIL 284 BS 75 mg tablet in healthy male volunteers.

    Study Document Trial synopsis 543.5 english
  • Amelubant - Healthy
    Clinical Study Number 543.7
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    The Effects of Multiple Doses of BIIL 284 BS on the Pharmacokinetics of a Single Dose of Theophylline in Healthy Male Volunteers (A Randomized, Double-Blind, Placebo­ Controlled, Two-period, Two-way Crossover Study)

    Study Document Trial synopsis 543.7_CO english

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