Value through Innovation27 July 2016

Clinical Study Results

  • BIRT 2584 - Healthy
    Clinical Study Number 1206.10
    Study Indication Healthy
    Product BIRT 2584
    Generic Name BIRT 2584
    Lab Code
    Clinical Phase I
    Study Title

    A study to evaluate the effect of multiple doses of 500 mg of BIRT 2584 XX tablets on the pharmacokinetic parameters of warfarin, omeprazole, caffeine, and dextromethorphan dosed orally and midazolam dosed IV, in healthy male volunteers

    Study Document Trial synopsis 1206.10_CO english
  • BIRT 2584 - Healthy
    Clinical Study Number 1206.12
    Study Indication Healthy
    Product BIRT 2584
    Generic Name BIRT 2584
    Lab Code
    Clinical Phase I
    Study Title

    A study to evaluate the effect of a single oral dose and multiple oral doses of 500 mg of BIRT 2584 XX tablets on the pharmacokinetic parameters of amitriptyline and nortriptyline in healthy male and female subjects

    Study Document Trial synopsis 1206.12_CO english
  • BIRT 2584 - Healthy
    Clinical Study Number 1206.2
    Study Indication Healthy
    Product BIRT 2584
    Generic Name BIRT 2584
    Lab Code
    Clinical Phase I
    Study Title

    Safety, pharmacokinetics, and pharmacodynamics of BIRT 2584 XX administered as multiple doses of 100 mg to 750 mg qd for 14 or 28 days (randomised, double-blind placebo controlled design), and safety and pharmacokinetics of 500 mg of BIRT 2584 XX administered with and without food as single dose (open, intra-individual comparison) to healthy male volunteers.

    Study Document Trial synopsis 1206.2 english
  • BIRT 2584 - Healthy
    Clinical Study Number 1206.9
    Study Indication Healthy
    Product BIRT 2584
    Generic Name BIRT 2584
    Lab Code
    Clinical Phase I
    Study Title

    To investigate the effect of BIRT 2584 XX and its metabolite BI 610100 when BIRT 2584 XX is administered as a tablet to near steady state in estimated high therapeutic dose on the PK of midazolam, a probe substrate for CYP 3A4. Midazolam PK will be measured before dosing of BIRT 2584 XX, after a single dose of BIRT 2584 XX and after repeated doses of BIRT 2584 XX for 3 and 12 days.

    Study Document Trial synopsis 1206.9 english
  • BIRT 2584 - Healthy
    Clinical Study Number 1206.1
    Study Indication Healthy
    Product BIRT 2584
    Generic Name BIRT 2584
    Lab Code
    Clinical Phase I
    Study Title

    Safety, pharmacokinetics, and pharmacodynamics of single rising oral doses of BIRT 2584 XX (5, 30, 100, 200, 350, 500, and 700 mg) as a solution in PEG 400 administered to healthy male volunteers. Placebo controlled and blinded at each dose level.

    Study Document Trial synopsis 1206.1 english
  • BIRT 2584 - Psoriasis
    Clinical Study Number 1206.5
    Study Indication Psoriasis
    Product BIRT 2584
    Generic Name BIRT 2584
    Lab Code
    Clinical Phase IIa/b
    Study Title

    A 12 week double-blind, randomised, placebo-controlled, modified dose escalation trial to investigate safety, efficacy, and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily inpatients with moderate to severe psoriasis with a 12 week treatment extensionfor PASI 50 responders.

    Study Document Trial synopsis 1206.5 english
  • BIRT 2584 - Multiple Sclerosis
    Clinical Study Number 1206.15
    Study Indication Multiple Sclerosis
    Product BIRT 2584
    Generic Name BIRT 2584
    Lab Code
    Clinical Phase IIb
    Study Title

    A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis

    Study Document Trial statement 1206.15 english

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

European Trial Register of EU studies.