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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005442-35 | EudraCT Number | EudraCT |
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The main objective of this study is to investigate the influence of mild, moderate and severe renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a control group with normal renal function after single dose of BI 201335.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 201335 relevant treatment dose (A) | Experimental | Capsule for oral administration |
|
| BI 201335 relevant treatment dose (B) | Experimental | Capsule for oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 201335 | Drug | Relevant treatment dose capsule (A) for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ | area under the concentration time curve of Faldaprevir in plasma over the time interval from 0 to infinity. In this endpoint, the data of AUC0-∞ show inter-individual variabilities. | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after administration |
| Cmax | maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities. | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00h after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG | Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. | from drug administration up to 2 weeks |
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Inclusion criteria:
Male and female healthy subjects with normal renal function and subjects with impaired renal function in relatively good health
Exclusion criteria:
Any relevant deviation from healthy conditions for healthy volunteers or significant diseases other than renal impairment for the renal impaired subjects
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1220.58.1 Boehringer Ingelheim Investigational Site | Kiel | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Renal Function | Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2 |
| FG001 | Mild Renal Impairment | Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2 |
| FG002 | Moderate Renal Impairment | Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2 |
| FG003 | Severe Renal Impairment | Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Renal Function | Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2 |
| BG001 | Mild Renal Impairment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC0-∞ | area under the concentration time curve of Faldaprevir in plasma over the time interval from 0 to infinity. In this endpoint, the data of AUC0-∞ show inter-individual variabilities. | Pharmacokinetic (PK) set: This subject set included all subjects in the treated set who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK, and who did not vomit at or before 2 times median tmax of unmetabolised faldaprevir. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after administration |
|
From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing)
Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BI 201335 Relevant Treatment Dose (Normal Renal Function) | Capsule for oral administration estimated glomerular filtration rate >= 90 mL/min/1.73m2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C552340 | faldaprevir |
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| BI 201335 | Drug | Relevant treatment dose capsule (B) for oral administration |
|
| Number of Participants With Drug Related Adverse Events | number of participants with investigator-defined drug related adverse events. | drug administration until end-of-study examination (7 to 14 days after drug administration) |
Capsule for oral administration (120 mg Faldaprevir)
subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2
| BG002 | Moderate Renal Impairment | Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2 |
| BG003 | Severe Renal Impairment | Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Mild Renal Impairment | Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2 |
| OG002 | Moderate Renal Impairment | Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2 |
| OG003 | Severe Renal Impairment | Capsule for oral administration (120 mg Faldaprevir) subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2 |
|
|
|
| Primary | Cmax | maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities. | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00h after administration |
|
|
|
|
| Secondary | Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG | Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. | treated set | Posted | Number | participants | from drug administration up to 2 weeks |
|
|
|
| Secondary | Number of Participants With Drug Related Adverse Events | number of participants with investigator-defined drug related adverse events. | treated set | Posted | Number | participants | drug administration until end-of-study examination (7 to 14 days after drug administration) |
|
|
|
| 0 |
| 8 |
| 5 |
| 8 |
| EG001 | BI 201335 Relevant Treatment Dose (Mild Renal Impairment) | Capsule for oral administration estimated glomerular filtration rate 60-89 mL/min/1.73m2 | 0 | 8 | 8 | 8 |
| EG002 | BI 201335 Relevant Treatment Dose (Moderate Renal Impairment) | Capsule for oral administration estimated glomerular filtration rate 30-59 mL/min/1.73m2 | 0 | 8 | 5 | 8 |
| EG003 | BI 201335 Relevant Treatment Dose (Severe Renal Impairment) | Capsule for oral administration estimated glomerular filtration rate 15-29 mL/min/1.73m2 | 0 | 8 | 7 | 8 |
| Gastrointestinal disorder | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MEDDRA 15.0 | Systematic Assessment |
|
| Blood pressure systolic increased | Investigations | MEDDRA 15.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
|
relative bioavailability comparison moderate : normal |
| ANOVA |
| Geometric Mean Ratio |
| 175.52 |
| Standard Deviation |
| 70.4 |
| 2-Sided |
| 90 |
| 89.55 |
| 344.06 |
the standard deviation is actually the geometric coefficient of variation |
| Yes |
| Non-Inferiority or Equivalence |
investigation of relative bioavailability (no formal testing) |
| relative bioavailability comparison severe : normal | ANOVA | Geometric Mean Ratio | 120.98 | Standard Deviation | 115 | 2-Sided | 90 | 47.257 | 309.736 | the standard deviation is actually the geometric coefficient of variation | Yes | Non-Inferiority or Equivalence | investigation of relative bioavailability (no formal testing) |
| blood pressure systolic increased |
|