Value through Innovation27 July 2016

Clinical Study Results

  • Deleobuvir - Healthy
    Clinical Study Number 1241.22
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    Metabolite profile, excretion balance and pharmacokinetics of BI 207127 NA combined with [14C]-BI 207127 NA in healthy adult male volunteers after an 800 mg single oral solution dose; a phase I, single-arm, open-label trial

    Study Document Trial synopsis 1241.22 english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.1
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, and pharmacokinetics of single rising oral doses (5 mg to 3000 mg) of BI 207127 NA as powder in the bottle reconstituted with PEG 400/Tris/SDS in healthy male subjects. A randomised, placebo-controlled and within dose groups double-blinded trial. Followed by an intra-individual, not randomised, open comparison of powder in the bottle without and with food.

    Study Document Trial synopsis 1241.1 english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.9
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of BI 207127 trial formulation II prototypes versus BI 207127 trial formulation I administered orally as tablet in single doses of 800 mg to healthy volunteers, and evaluation of the effect of food on the bioavailability of a selected prototype (an open-label, two-stage, within parts randomised six-way and two-way crossover phase I study)

    Study Document Trial synopsis 1241.9_CO english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.18
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, fixed sequence Phase I study in healthy male volunteers to assess sequentially the effects of multiple doses of BI 207127 NA, BI 201335 NA followed by the combination of BI 207127 NA and BI 201335 NA, on the single dose pharmacokinetics of midazolam and tolbutamide and on the systemic exposure of BI 207127 NA and BI 201335 NA

    Study Document Trial synopsis 1241.18_CO english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.42
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, assessor-blind, placebo and active controlled, parallel group study to assess the phototoxic potential of Faldaprevir (administered orally, once daily) for 6 days in healthy male and female subjects

    Study Document Trial synopsis 1241.42 english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.8
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, and pharmacokinetics of single rising oral doses (400 mg , 800 mg, 1200 mg) of BI 207127 NA in healthy male Asian volunteers and single oral dose (1200 mg) of BI 207127 NA in healthy male Caucasian volunteers (randomised, double-blind, placebo-controlled within dose groups)

    Study Document Trial synopsis 1241.8 english
  • Deleobuvir - Hepatitis C, Chronic
    Clinical Study Number 1241.30
    Study Indication Hepatitis C, Chronic
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase IIb
    Study Title

    A phase IIb open label study of BI 207127 in combination with faldaprevir and ribavirin in patients with moderate hepatic impairment (Child-Pugh B) with genotype 1b chronic hepatitis C infection

    Study Document Trial synopsis 1241.30_DR english
  • Deleobuvir - Hepatitis C, Chronic
    Clinical Study Number 1241.21
    Study Indication Hepatitis C, Chronic
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase Ib/II
    Study Title

    Safety, antiviral effect and pharmacokinetics of BI 207127 in combination with BI 201335 and with or without ribavirin for 4, 16, 24, 28 or 40 weeks in patients with chronic HCV genotype 1 infection (randomized Phase Ib/II)

    Study Document Trial synopsis 1241.21_DR english
  • Deleobuvir - Hepatitis C, Chronic
    Clinical Study Number 1241.2
    Study Indication Hepatitis C, Chronic
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase Ib
    Study Title

    Safety, antiviral activity, and pharmacokinetics of multiple oral doses of BI 207127 NA administered q8H for 5 days as monotherapy, a randomised, double-blind, placebo controlled study

    Study Document Trial synopsis 1241.2_DS_DR english
  • Deleobuvir - Hepatitis C, Chronic
    Clinical Study Number 1241.20
    Study Indication Hepatitis C, Chronic
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, Randomized, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination with Faldaprevir and Ribavirin in Treatment-Naive Patients with Chronic Genotype 1 HCV Infection

    Study Document Trial synopsis 1241.20_DR english
  • Deleobuvir - Hepatitis C, Chronic
    Clinical Study Number 1241.25
    Study Indication Hepatitis C, Chronic
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase IIa
    Study Title

    An open-label, ascending dose, phase II study to evaluate tolerability, safety, antiviral activity, and pharmacokinetics of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8 weeks in treatment-naive Japanese patients with genotype 1chronic hepatitis C virus infection

    Study Document Trial synopsis 1241.25_DR english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.26
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of BI 207127 FF tablets, BI 207127 FF modified tabletsand BI 207127 TFII tablets administered orally as three tablets (single dose) tohealthy male volunteers, an open-label, randomised three-way crossover study

    Study Document Trial synopsis 1241.26_DS_DR english
  • Deleobuvir - Hepatitis C, Chronic
    Clinical Study Number 1241.27
    Study Indication Hepatitis C, Chronic
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase Ib
    Study Title

    A multi-centre, open label, parallel group trial to evaluate the pharmacokinetic interactions between BI 207127 (600 mg t.i.d. or 600 mg b.i.d.) and BI 201335 (120 mg q.d.) given in combination with ribavirin for 24 weeks, and their combined effect on the pharmacokinetics of tenofovir, raltegravir, caffeine (the probe drug substrate for CYP1A2), tolbutamide (the probe drug substrate for CYP2C9) and midazolam (the probe drug substrate for CYP3A4) in treatment naive patients and prior treatment relapse or partial responder patients with genotype 1 chronic hepatitis C infection

    Study Document Trial synopsis 1241.27_DR english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.31
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, two-period, fixed-sequence, phase I trial to evaluate the effect of multiple doses of BI 207127 + faldaprevir on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel in healthy premenopausal female subjects

    Study Document Trial synopsis 1241.31 english
  • Deleobuvir - Renal Insufficiency
    Clinical Study Number 1241.32
    Study Indication Renal Insufficiency
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase 1241.32
    Study Title

    Pharmacokinetics, safety and tolerability of the combination of BI 207127 and faldaprevir in patients with different degrees of renal impairment in comparison to subjects with normal renal function in a single center, open-label, parallel-group, phase I trial

    Study Document Trial synopsis 1241.32 english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.35
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, multiple dose study to assess safety, tolerability and pharmacokinetics of different multiple doses of BI 207127 BID administered orally for 9 days (Part 1) and multiple doses of BI 207127 combined with faldaprevir administered orally for 16 days (Part 2) in healthy male and female subjects

    Study Document Trial synopsis 1241.35 english
  • Deleobuvir - Hepatitis C, Chronic
    Clinical Study Number 1241.36
    Study Indication Hepatitis C, Chronic
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase III
    Study Title

    A phase III randomised, partially double-blind and placebo-controlled study of BI 207127 in combination with faldaprevir and ribavirin for chronic genotype 1 hepatitis C infection in an extended population of treatment naive patients that includes those ineligible to receive peginterferon

    Study Document Trial synopsis 1241.36 english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.40
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    Thorough QT study to evaluate the effects of BI 207127 (Deleobuvir) combined with Faldaprevir on cardiac safety parameters in healthy female and male subjects. Randomised, placebo controlled, single-blind, three-period crossover Phase-I-study with moxifloxacin as positive control

    Study Document Trial synopsis 1241.40_DR english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.44
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of the effect of food and of increased gastric pH on the relative bioavailability of deleobuvir following single oral administration in healthy Caucasian and Japanese subjects (an open-label, randomised, four-way crossover study)

    Study Document Trial synopsis 1241.44 english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.61
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of potential drug-drug interactions between faldaprevir and immunosuppressants (cyclosporine and tacrolimus) in healthy male and female subjects (open-label, fixed-sequence trial)

    Study Document Trial synopsis 1241.61 english
  • Deleobuvir - Hepatitis C, Chronic
    Clinical Study Number 1241.7
    Study Indication Hepatitis C, Chronic
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase Ib
    Study Title

    Safety, antiviral activity, and pharmacokinetics of BI 207127 NA administered in combination with Peg-IFN and ribavirin in chronic HCV-infected patients for 4 weeks, a randomised, double-blind, placebo controlled study

    Study Document Trial synopsis 1241.7_DS_DR english
  • Deleobuvir - Hepatitis C, Chronic
    Clinical Study Number 1241.37
    Study Indication Hepatitis C, Chronic
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, open label, active-controlled study of an interferon-free regimen of BI 207127 in combination with Faldaprevir and Ribavirin compared to Telaprevir in combination with pegylated interferon-a and ribavirin in treatment-naive patients with chronic genotype 1b Hepatitis C Virus infection

    Study Document Trial statement 1241.37 english

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