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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005690-31 | EudraCT Number | EudraCT |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo to BI 1026706 | Placebo Comparator | Multiple Rising Doses Placebo to BI 1026706 |
|
| BI 1026706 | Experimental | Multiple Rising Doses BI 1026706 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1026706 | Drug | Multiple Rising Doses (oral solution, tablet) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Drug Related Adverse Events | Percentage of subjects with drug related adverse events (AEs) | From first drug administration until 3 days after last drug administration, 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measured Concentration (Cmax) | Maximum measured concentration of the analyte in plasma (Cmax) | 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin |
| Time From Dosing to Maximum Measured Concentration (Tmax) |
Not provided
Inclusion criteria:
Males or females without any clinically relevant medical disorders according to the investigator's assessment, as based on the following: a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
For OA patients: Evidence of OA of the knee by radiography or by magnetic resonance tomography (Kellgren-Lawrence grade 1, 2, or 3; excluding grades 0 and 4) of the knee (tibiofemoral joint only) within the last 5 years consistent with the clinical diagnosis of osteoarthritis of the knee according to American College of Rheumatology (ACR) guidelines
For OA patients: American Rheumatism Association (ARA) functional class I, II, or III
For OA patients: Average pain in the index knee over the previous 48 hours greater than or equal to 4 on the 11-item Likert scale at two time points: 1) at screening (if not on analgesic medication) or after 3 days of wash-out of analgesic medication, and 2) in the evening prior to randomisation
For OA patients: Presence of bothersome OA related pain for most days within the last month prior to screening at the investigator's discretion, or pain requiring analgesic treatment on more than 3 days per week during the last month prior to screening.
Age 35 to 65 years (inclusive)
BMI (Body Mass Index) 18.5 to 33 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Females who meet any of the following criteria from at least 30 days before the first study drug administration and until 30 days after trial completion:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1320.2.2 Boehringer Ingelheim Investigational Site | Berlin | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo HV | Healthy volunteers (HV) received a matching placebo containing quinine sulphate dehydrate, once daily for 12 days. |
| FG001 | 50mg BI 1026706 HV | Healthy volunteers (HV) received 50mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo to BI 1026706 |
| Drug |
Multiple Rising Doses (oral solution / tablet, identical to active treatment) |
|
Time from dosing to maximum measured concentration of the analyte in plasma (Tmax) |
| 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin. |
| Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 24h (AUC0-24) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24 hours (h) (AUC0-24). | 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin |
| Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 12h (AUC0-12) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 12 hours (h) (AUC0-12). | 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h and 12h after first drug admin |
| Maximum Measured Concentration at Steady-state (Cmax,ss) | Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval Ï„ (Cmax,ss). | 5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12 |
| Time From Last Dosing to Maximum Measured Concentration at Steady-state (Tmax,ss) | Time from last dosing to maximum concentration of the analyte in plasma at steady-state (Tmax,ss). | 5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12 |
| Area Under the Concentration-time Curve at Steady-state (AUCÏ„,ss) | Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval Ï„ (AUCÏ„,ss). | 5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12 |
| FG002 | 100mg BI 1026706 HV | Healthy volunteers (HV) received 100mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution. |
| FG003 | 300mg BI 1026706 HV | Healthy volunteers (HV) received 300mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution. |
| FG004 | Placebo OA | Patients with osteoarthritis (OA) received a matching placebo containing quinine sulphate dehydrate, once daily for 12 days. |
| FG005 | 200mg BI 1026706 OA | Patients with osteoarthritis received 200mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution. |
| FG006 | 100mg BI 1026706 BID OA | Patients with osteoarthritis received oral administration of 100mg BI 1026706 tablets twice daily (BID) on days 2 to 11 and once daily on days 1 and 12. |
| COMPLETED |
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| NOT COMPLETED |
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Treated set (TS) which included all randomised patients and healthy subjects who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo HV | Healthy volunteers (HV) received a matching placebo containing quinine sulphate dehydrate, once daily for 12 days. |
| BG001 | 50mg BI 1026706 HV | Healthy volunteers (HV) received 50mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution. |
| BG002 | 100mg BI 1026706 HV | Healthy volunteers (HV) received 100mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution. |
| BG003 | 300mg BI 1026706 HV | Healthy volunteers (HV) received 300mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution. |
| BG004 | Placebo OA | Patients with osteoarthritis (OA) received a matching placebo containing quinine sulphate dehydrate, once daily for 12 days. |
| BG005 | 200mg BI 1026706 OA | Patients with osteoarthritis received 200mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution. |
| BG006 | 100mg BI 1026706 BID OA | Patients with osteoarthritis received oral administration of 100mg BI 1026706 tablets twice daily (BID) on days 2 to 11 and once daily on days 1 and 12. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With Drug Related Adverse Events | Percentage of subjects with drug related adverse events (AEs) | Treated set (TS) | Posted | Number | Percentage of participants | From first drug administration until 3 days after last drug administration, 15 days |
|
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| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Measured Concentration (Cmax) | Maximum measured concentration of the analyte in plasma (Cmax) | Pharmacokinetic set (PKS) which included all patients and healthy subjects in the TS who provided at least 1 PK endpoint value without relevant protocol deviations with respect to the evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin |
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| Secondary | Time From Dosing to Maximum Measured Concentration (Tmax) | Time from dosing to maximum measured concentration of the analyte in plasma (Tmax) | PKS | Posted | Median | Full Range | hours | 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin. |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 24h (AUC0-24) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24 hours (h) (AUC0-24). | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 12h (AUC0-12) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 12 hours (h) (AUC0-12). | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h and 12h after first drug admin |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Measured Concentration at Steady-state (Cmax,ss) | Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval Ï„ (Cmax,ss). | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time From Last Dosing to Maximum Measured Concentration at Steady-state (Tmax,ss) | Time from last dosing to maximum concentration of the analyte in plasma at steady-state (Tmax,ss). | PKS | Posted | Median | Full Range | hours | 5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve at Steady-state (AUCÏ„,ss) | Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval Ï„ (AUCÏ„,ss). | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12 |
|
From first drug administration until 3 days after last drug administration, 15 days
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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 | Placebo HV | Healthy volunteers (HV) received a matching placebo containing quinine sulphate dehydrate, once daily for 12 days. | 0 | 9 | 5 | 9 | ||
| EG001 | 50mg BI 1026706 HV | Healthy volunteers (HV) received 50mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution. | 0 | 9 | 3 | 9 | ||
| EG002 | 100mg BI 1026706 HV | Healthy volunteers (HV) received 100mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution. | 0 | 9 | 2 | 9 | ||
| EG003 | 300mg BI 1026706 HV | Healthy volunteers (HV) received 300mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution. | 0 | 9 | 6 | 9 | ||
| EG004 | Placebo OA | Patients with osteoarthritis (OA) received a matching placebo containing quinine sulphate dehydrate, once daily for 12 days. | 0 | 5 | 3 | 5 | ||
| EG005 | 200mg BI 1026706 OA | Patients with osteoarthritis received 200mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution. | 0 | 9 | 6 | 9 | ||
| EG006 | 100mg BI 1026706 BID OA | Patients with osteoarthritis received oral administration of 100mg BI 1026706 tablets twice daily (BID) on days 2 to 11 and once daily on days 1 and 12. | 0 | 8 | 4 | 8 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | 17.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | 17.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | 17.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | 17.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | 17.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | 17.1 | Systematic Assessment |
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| Abnormal faeces | Gastrointestinal disorders | 17.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | 17.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | 17.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | 17.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | 17.1 | Systematic Assessment |
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| Gastric disorder | Gastrointestinal disorders | 17.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | 17.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | 17.1 | Systematic Assessment |
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| Asthenia | General disorders | 17.1 | Systematic Assessment |
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| Chills | General disorders | 17.1 | Systematic Assessment |
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| Fatigue | General disorders | 17.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | 17.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | 17.1 | Systematic Assessment |
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| Pancreatic enzymes increased | Investigations | 17.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | 17.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | 17.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 17.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | 17.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | 17.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | 17.1 | Systematic Assessment |
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| Headache | Nervous system disorders | 17.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | 17.1 | Systematic Assessment |
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| Tension headache | Nervous system disorders | 17.1 | Systematic Assessment |
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| Agitation | Psychiatric disorders | 17.1 | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | 17.1 | Systematic Assessment |
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| Menorrhagia | Reproductive system and breast disorders | 17.1 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | 17.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 17.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 17.1 | Systematic Assessment |
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| Haematoma | Vascular disorders | 17.1 | 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 |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| Male |
|
Patients with osteoarthritis received 200mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution. |
| OG004 | 100mg BI 1026706 BID OA | Patients with osteoarthritis received oral administration of 100mg BI 1026706 tablets twice daily (BID) on days 2 to 11 and once daily on days 1 and 12. |
|
|
|
| OG004 | 100mg BI 1026706 BID OA | Patients with osteoarthritis received oral administration of 100mg BI 1026706 tablets twice daily (BID) on days 2 to 11 and once daily on days 1 and 12. |
|
|
Patients with osteoarthritis received 200mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
| OG004 | 100mg BI 1026706 BID OA | Patients with osteoarthritis received oral administration of 100mg BI 1026706 tablets twice daily (BID) on days 2 to 11 and once daily on days 1 and 12. |
|
|
|
Patients with osteoarthritis received 200mg BI 1026706 once daily on days 1 to 12 in the form of a powder for oral solution.
| OG004 | 100mg BI 1026706 BID OA | Patients with osteoarthritis received oral administration of 100mg BI 1026706 tablets twice daily (BID) on days 2 to 11 and once daily on days 1 and 12. |
|
|
| OG004 | 100mg BI 1026706 BID OA | Patients with osteoarthritis received oral administration of 100mg BI 1026706 tablets twice daily (BID) on days 2 to 11 and once daily on days 1 and 12. |
|
|
|
| OG004 | 100mg BI 1026706 BID OA | Patients with osteoarthritis received oral administration of 100mg BI 1026706 tablets twice daily (BID) on days 2 to 11 and once daily on days 1 and 12. |
|
|
| OG004 | 100mg BI 1026706 BID OA | Patients with osteoarthritis received oral administration of 100mg BI 1026706 tablets twice daily (BID) on days 2 to 11 and once daily on days 1 and 12. |
|
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