Value through Innovation27 July 2016

Clinical Study Results

  • Faldaprevir - Healthy
    Clinical Study Number 1220.59
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of the effect of food and of increased gastric pH on the relative bioavailability of a single oral dose of 240 mg faldaprevir in an open-label, randomised, three-way crossover trial in healthy subjects

    Study Document Trial synopsis 1220.59 english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.61
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of interactions between faldaprevir, itraconazole, atorvastatin and rosuvastatin in healthy male and female subjects (open-label, fixed-sequence)

    Study Document Trial synopsis 1220.61 english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.65
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of faldaprevir effect on steady state pharmacokinetics of raltegravir in healthy male and female volunteers (an open-label trial with two periods in a fixed sequence)

    Study Document Trial synopsis 1220.65 english
  • Faldaprevir - Hepatitis C, Chronic
    Clinical Study Number 1220.19
    Study Indication Hepatitis C, Chronic
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase III
    Study Title

    Safety and Efficacy of 120 mg and 240 mg BI 201335 once daily in combination with pegylated interferon alpha 2a and ribavirin for treatment of chronic Hepatitis C (HCV) genotype 1 infection in HIV/HCV-co-infected patients. A multinational, randomised, parallel group, open-label trial.

    Study Document Trial synopsis 1220.19_DR english
  • Faldaprevir - Hepatitis C, Chronic
    Clinical Study Number 1220.2
    Study Indication Hepatitis C, Chronic
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase Ib
    Study Title

    Safety, antiviral activity, and pharmacokinetics of multiple rising oral doses of BI 201335 NA in treatment-naive patients with chronic hepatitis C infection for14 days monotherapy followed by combination with Pegylated Interferon and Ribavirin for an additional 14 days (double-blind, placebo controlled); and in treatment-experienced patients with chronic hepatitis C infection for 28 days as combination therapy with Pegylated Interferon and Ribavirin (open-label)

    Study Document Trial synopsis 1220.2_PE_DS_DR english Trial synopsis 1220.2_DS_DR english
  • Faldaprevir - Hepatitis C, Chronic
    Clinical Study Number 1220.5
    Study Indication Hepatitis C, Chronic
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase II
    Study Title

    Antiviral effect, safety, and pharmacokinetics of BI 201335 NA in hepatitis C virus genotype 1 infected treatment-naive and treatment-experienced patients for 24 weeks as combination therapy with pegylated interferon ?-2a and ribavirin (double blinded, randomised, placebo controlled, Phase II)

    Study Document Trial synopsis 1220.5_DS_DR english
  • Faldaprevir - Hepatitis C, Chronic
    Clinical Study Number 1220.7
    Study Indication Hepatitis C, Chronic
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, double-blind and placebo controlled study of once daily BI 201335, 240 mg for 12 or 24 weeks in combination with pegylated interferon-a (PegIFNa) and ribavirin (RBV) in patients with genotype 1 chronic hepatitis C infection who failed a prior PegIFN/RBV treatment

    Study Document Trial synopsis 1220.7_DR english
  • Faldaprevir - Hepatitis C
    Clinical Study Number 1220.14
    Study Indication Hepatitis C
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase IIa
    Study Title

    Safety, pharmacokinetics and antiviral effect of BI 201335 NA in HCV-1 infected patients treated for 28 days for treatment naive and experienced patients treated in combination with Peg Interferon ?-2a and ribavirin

    Study Document Trial synopsis 1220.14_DS_DR english
  • Faldaprevir - Hepatitis C
    Clinical Study Number 1220.15
    Study Indication Hepatitis C
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    An open label single dose phase I trial of 120 mg and 240 mg BI 201335 soft gel capsules to study pharmacokinetic properties and safety in patients with compensated liver cirrhosis in historical comparison with 1220.2

    Study Document Trial synopsis 1220.15_DS_DR english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.20
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Effect of multiple dosing with 240mg q 12hrs BI 201335 on the pharmacokinetics of 50 mg single dose efavirenz and effect of multiple dosing with 600 mg QDefavirenz on CYP3A and the pharmacokinetics of BI 201335 in healthy volunteers

    Study Document Trial synopsis 1220.20 english
  • Faldaprevir - Hepatitis C
    Clinical Study Number 1220.30
    Study Indication Hepatitis C
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, double-blind and placebo-controlled study of once daily faldaprevir 120 mg for 12 or 24 weeks or faldaprevir 240 mg for 12 weeks in combination with pegylated interferon-? and ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C infection

    Study Document Trial synopsis 1220.30_DR english
  • Faldaprevir - Hepatitis C
    Clinical Study Number 1220.40
    Study Indication Hepatitis C
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase II
    Study Title

    Antiviral effect and safety of once daily BI 201335 NA in hepatitis C virus genotype 1 infected treatment-naive patients for 12 or 24 weeks as combination therapy with pegylated interferon-? 2a and ribavirin (open-label, randomised, Phase II)

    Study Document Trial synopsis 1220.40_DS_DR english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.46
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of BI 201335 (capsule) compared to three different oral solutions of BI 201335 following oral administration in healthy male and female volunteers (an open-label, randomised, single-dose, four-way crossover study)

    Study Document Trial synopsis 1220.46_DS_DR english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.49
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Effect of multiple dosing with 240 mg QD BI 201335 on the steady-state pharmacokinetics of 800 mg QD darunavir coadministered with 100 mg QD ritonavir (DRV/r) in healthy male and female volunteers (an open-label, multiple-dose, single group, single fixed sequence phase I study)

    Study Document Trial synopsis 1220.49 english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.50
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Effect of multiple dosing with 240 mg BID BI 201335 on the steady state pharmacokinetics of 300mg QD Tenofovir and effect of multiple dosing with 300mg QD Tenofovir on steady state BI 201335 pharmacokinetics in healthy male and female volunteers

    Study Document Trial synopsis 1220.50 english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.52
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics of single and multiple oral doses of 120 mg and 240 mg faldaprevir in healthy Chinese volunteers

    Study Document Trial synopsis 1220.52 english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.53
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Assessment of bioequivalence between two different formulations of BI 201335 NA soft gelatine capsules in healthy male volunteers. (an open-label, randomised, single-dose, four-period replicated crossover study)

    Study Document Trial synopsis 1220.53 english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.56
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, two-period, fixed-sequence, phase I trial to evaluate the effect ofmultiple doses of 240 mg BI 201335 QD on the multiple-dose pharmacokineticsof a combination of ethinylestradiol and levonorgestrel in healthy pre menopausal female volunteers

    Study Document Trial synopsis 1220.56 english
  • Faldaprevir - Opiate Substitution Treatment
    Clinical Study Number 1220.57
    Study Indication Opiate Substitution Treatment
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase Ib
    Study Title

    Effect of multiple dosing with BI 201335 on the safety, pharmacokinetics and pharmacodynamics of steady-state methadone and buprenorphine/naloxone in subjects on stable addiction management therapy

    Study Document Trial synopsis 1220.57_DS_DR english
  • Faldaprevir - Renal Insufficiency
    Clinical Study Number 1220.58
    Study Indication Renal Insufficiency
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, safety and tolerability of BI 201335 in patients with different degrees of renal impairment in comparison to subjects with normal renal function in a monocentric, open-label, parallel-group, phase I trial

    Study Document Trial synopsis 1220.58 english
  • Faldaprevir - Hepatitis C, Chronic
    Clinical Study Number 1220.47
    Study Indication Hepatitis C, Chronic
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, double-blind and placebo-controlled study of once daily BI 201335 120 mg for 24 weeks and BI 201335 240 mg for 12 weeks in combination with pegylated interferon-? and ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C infection

    Study Document Trial synopsis 1220.47_DR english
  • Faldaprevir - Hepatitis C, Chronic
    Clinical Study Number 1220.48
    Study Indication Hepatitis C, Chronic
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, open-label study of once daily BI 201335 240 mg for 24 weeks in combination with pegylated interferon-? (PegIFN) and ribavirin (RBV) in patients with genotype 1 chronic hepatitis C infection who failed a priorPegIFN / RBV treatment

    Study Document Trial synopsis 1220.48_DR english
  • Faldaprevir - Hepatitis C, Chronic
    Clinical Study Number 1220.54
    Study Indication Hepatitis C, Chronic
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase III
    Study Title

    Safety, efficacy and pharmacokinetics of BI 201335 NA in patient with genotype 1 chronic hepatitis C virus infection in combination with pegylated interferon alfa-2b and ribavirin - Cohort 1 for treatment-naive patients: randomised, double-blind part of BI 201335 NA for 12 or 24 weeks - Cohort 2 for treatment-experienced patients: open-label part of BI 201335 NA for 24 weeks

    Study Document Trial synopsis 1220.54_DR english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.1
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerance, and pharmacokinetics of single oral doses of 5 mg, 20 mg, 60mg, 150 mg, 300 mg, 600 mg, 1000 mg, and 1500 mg BI 201335 ZW (PEG400/TRIS/water solution) in healthy male subjects, in a randomised double blind, placebo controlled rising dose study, followed with an open-label intrasubject two-stage crossover pilot bioavailability comparison of 600 mg BI201335 ZW in a PEG 400/TRIS/water solution co-administered with food.

    Study Document Trial synopsis 1220.1_CO english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.3
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerance, and pharmacokinetics of single oral doses of 4 mg, 16 mg,48 mg, 120 mg, 240 mg, 480 mg, 800 mg, and 1200 mg BI 201335 NA (PEG 400/TRIS/meglumine/water solution) in healthy male subjects, in a randomised single blind, placebo controlled rising dose study, followed with an open-label intra-subject two-stage crossover pilot bioavailability comparison of 480 mg BI 201335 NA in a PEG 400/TRIS/meglumine/water solution coadministered with food

    Study Document Trial synopsis 1220.3_CO english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.6
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of multiple rising oral doses of 20 mg, 48 mg, 120 mg, and 240 mg once a day of BI 201335 NA (oral solution) in healthy male subjects, in a randomized double blind, placebo controlled study

    Study Document Trial synopsis 1220.6_CO english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.9
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    An open label fixed sequence Phase I study to investigate the effect of BI 201335 mediated UGT1A1 inhibition on the multiple oral dose pharmacokinetics of raltegravir (Isentress®) in healthy male and female volunteers

    Study Document Trial synopsis 1220.9_CO english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.10
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, randomized, crossover relative bioavailability study of a new soft gelatin capsule formulation of BI 201335 NA compared to the current solution formulation (powder in bottle (PIB)), after single dose oral administration in healthy volunteers

    Study Document Trial synopsis 1220.10_CO english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.13
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, and pharmacokinetics of single rising oral doses (40 mg to 480 mg) of BI 201335 NA as capsule(s) administered to healthy male subjects – a randomised, placebo-controlled (within dose groups) and double-blind trial

    Study Document Trial synopsis 1220.13_CO english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.16
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Assessment of the effect of 480 mg and 1200 mg of BI 201335 as single dose on the QT interval in healthy female and male subjects; a randomised, placebo-controlled, double-blind, four-way crossover Phase I study with moxifloxacin as positive control

    Study Document Trial synopsis 1220.16_CO english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.32
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Evaluation of the effects of single oral dose and multiple oral doses of BI 201335 NA on Cytochrome P450 and P-glycoprotein activity using a probe drug cocktail. An open-label, single-arm Phase I study in healthy human volunteers

    Study Document Trial synopsis 1220.32_CO english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.33
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Metabolism and pharmacokinetics of a single dose of 240 mg [14C]-BI 201335 given as oral solution to healthy male volunteers at steady state of BI 201335 NA maintained with oral capsules of 240 mg BI 201335, a phase I, single-arm, open-label trial

    Study Document Trial synopsis 1220.33_CO english

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