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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000505-41 | EudraCT Number | EudraCT |
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The objective of the current study is to investigate the effect of multiple oral daily doses of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with ritonavir.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 201335 | Experimental | capsule for oral administration |
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| Darunavir 400 mg | Experimental | tablet for oral administration |
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| Ritonavir 100 mg | Experimental | tablet for oral administration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darunavir | Drug | 400 mg tablet for oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| AUCτ,ss of Darunavir | area under the concentration-time curve of the analyte in plasma at steadystate over a uniform dosing interval τ of darunavir. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r) |
| Cτ,ss of Darunavir | concentration of the analyte in plasma at steady-state after a uniform dosing interval τ=24h of darunavir | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r) |
| Cmax,ss of Darunavir | maximum measured concentration of the analyte in plasma at steady-state | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r) |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax,ss of Darunavir | time from last dosing to maximum concentration of the analyte in plasma at steady state | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1220.49.1 Boehringer Ingelheim Investigational Site | Berlin | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers. Period 1: Darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r). Period 2: Faldaprevir together with DRV/r. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Ritonavir |
| Drug |
tablet for oral administration |
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| BI 201335 | Drug |
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| COMPLETED |
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| NOT COMPLETED |
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The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers. Period 1: darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r). Period 2: faldaprevir together with DRV/r. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | AUCτ,ss of Darunavir | area under the concentration-time curve of the analyte in plasma at steadystate over a uniform dosing interval τ of darunavir. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities | Pharmacokinetic (PK) set: all subjects in the treated set who provided at least one observation for at least one primary endpoint without any important protocol violations relevant to the pharmacokinetic evaluation and who did not experience vomiting at or before 2 times median tmax. | 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, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r) |
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| Primary | Cτ,ss of Darunavir | concentration of the analyte in plasma at steady-state after a uniform dosing interval τ=24h of darunavir | 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, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r) |
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| Primary | Cmax,ss of Darunavir | maximum measured concentration of the analyte in plasma at steady-state | 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, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r) |
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| Secondary | Tmax,ss of Darunavir | time from last dosing to maximum concentration of the analyte in plasma at steady state | PK set | Posted | Median | Full Range | h | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r) |
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Adverse events (AEs) occurring up to 9 days after first drug administration of DRV/r were assigned to the treatment DRV/r and AEs occurring up to 13 days after last drug administration of DRV/r+FDV were assigned to the combined treatment DRV/r+FDV.
The subjects were required to spontaneously report any AEs. In addition, subjects were assessed regularly for AEs during the trial.
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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 | Darunavir+Ritonavir | oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r)once daily | 0 | 14 | 7 | 14 | ||
| EG001 | Faldaprevir+Darunavir+Ritonavir | oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day. | 0 | 14 | 11 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | MEDDRA 14.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MEDDRA 14.0 | Systematic Assessment |
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| Nervousness | Psychiatric disorders | MEDDRA 14.0 | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MEDDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MEDDRA 14.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MEDDRA 14.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MEDDRA 14.0 | Systematic Assessment |
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| Eye haemorrhage | Eye disorders | MEDDRA 14.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MEDDRA 14.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MEDDRA 14.0 | Systematic Assessment |
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| Fatigue | General disorders | MEDDRA 14.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069454 | Darunavir |
| D019438 | Ritonavir |
| C552340 | faldaprevir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
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