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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004615-23 | EudraCT Number | EudraCT |
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Investigation of safety and tolerability of BI 1034020 in healthy male volunteers following intravenous (IV) infusion of subcutaneous (SC) injection of single doses and exploration of the pharmacokinetics and pharmacodynamics of BI 1034020 after single dosing and determination of the bioavailability of subcutaneous injections of BI 1034020
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1034020 intravenous part | Experimental | single rising doses |
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| BI 1034020 subcutaneous part | Experimental | single rising doses |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1034020 | Drug | intravenous part |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Drug Related Adverse Events | Percentage of subjects with investigator defined drug-related adverse events | from the first drug administration to end of trial, up to 50 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum measured concentration of BI 1034020 in plasma (Cmax). | 2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1. |
| AUC0-inf |
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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 |
|---|---|---|---|---|---|---|
| 1312.1.1 Boehringer Ingelheim Investigational Site | Biberach | Germany | ||||
| 1312.1.2 Boehringer Ingelheim Investigational Site |
Partially randomised, placebo-controlled within dose groups, single-blind, single rising dose, multiple centres (dose escalation intravenous [iv] bridging to subcutaneous [sc] in parallel). 35 subjects were enrolled and 32 subjects were treated.
This trial was initiated at two centres. As one of the trial centres did not enrol any subjects by the time of premature termination of the trial; the trial was conducted only at one centre.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning. |
| FG001 | BI 1034020 (5 mg/25 mL - iv) | Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo to BI 1034020 | Drug | intravenous part |
|
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). AUC0-inf could be assessed only in 50 mg iv dose group as terminal phase was below lower limit of quantification (BLQ) for other dose groups. Therefore dose proportionality for AUC0-inf could not be performed in this trial. |
| 2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1. |
| AUC0-tz | Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose (AUC0-tz ). | 2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1. |
| Ingelheim |
| Germany |
| FG002 | BI 1034020 (10 mg/25 mL - iv) | Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. |
| FG003 | BI 1034020 (20 mg/25 mL - iv) | Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. |
| FG004 | BI 1034020 (50 mg/25 mL - iv) | Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. |
| FG005 | BI 1034020 (100 mg/25 mL - iv) | Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. |
| COMPLETED |
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| NOT COMPLETED |
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Treated set (TS):This subject set included all subjects who were dispensed study medication and were documented to have received 1 dose of trial medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning. |
| BG001 | BI 1034020 (5 mg/25 mL - iv) | Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. |
| BG002 | BI 1034020 (10 mg/25 mL - iv) | Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. |
| BG003 | BI 1034020 (20 mg/25 mL - iv) | Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. |
| BG004 | BI 1034020 (50 mg/25 mL - iv) | Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. |
| BG005 | BI 1034020 (100 mg/25 mL - iv) | Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. |
| BG006 | Total | Total of all reporting groups |
| 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 | Year |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 investigator defined drug-related adverse events | Treated Set (TS) | Posted | Number | percentage of participants | from the first drug administration to end of trial, up to 50 days |
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| Secondary | Cmax | Maximum measured concentration of BI 1034020 in plasma (Cmax). | Pharmacokinetic Set (PKS): This subject set included all subjects in the treated set who provide at least 1 observation for at least 1 secondary Pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | 2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1. |
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| Secondary | AUC0-inf | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). AUC0-inf could be assessed only in 50 mg iv dose group as terminal phase was below lower limit of quantification (BLQ) for other dose groups. Therefore dose proportionality for AUC0-inf could not be performed in this trial. | Pharmacokinetic set (PKS): | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*h/mL | 2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1. |
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| Secondary | AUC0-tz | Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose (AUC0-tz ). | Pharmacokinetic set (PKS) | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*h/mL | 2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1. |
|
from the first drug administration to end of trial, up to 50 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 | Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning. | 0 | 8 | 6 | 8 | ||
| EG001 | BI 1034020 (5 mg/25 mL - iv) | Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. | 0 | 6 | 3 | 6 | ||
| EG002 | BI 1034020 (10 mg/25 mL - iv) | Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. | 0 | 6 | 4 | 6 | ||
| EG003 | BI 1034020 (20 mg/25 mL - iv) | Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. | 0 | 5 | 3 | 5 | ||
| EG004 | BI 1034020 (50 mg/25 mL - iv) | Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. | 0 | 6 | 5 | 6 | ||
| EG005 | BI 1034020 (100 mg/25 mL - iv) | Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. | 1 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactoid reaction | Immune system disorders | MEDDRA 17.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MEDDRA 17.0 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MEDDRA 17.0 | Systematic Assessment |
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| Photopsia | Eye disorders | MEDDRA 17.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Faeces discoloured | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Chest discomfort | General disorders | MEDDRA 17.0 | Systematic Assessment |
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| Fatigue | General disorders | MEDDRA 17.0 | Systematic Assessment |
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| Injection site haematoma | General disorders | MEDDRA 17.0 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MEDDRA 17.0 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MEDDRA 17.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MEDDRA 17.0 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MEDDRA 17.0 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MEDDRA 17.0 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MEDDRA 17.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MEDDRA 17.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MEDDRA 17.0 | Systematic Assessment |
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Due to a drug-related Serious Adverse event in the first subject of 100 mg BI 1034020 single iv dose group, the trial was prematurely terminated. No further iv dosing was performed and no planned sc dosing scheme was performed in this trial.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Male |
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| BI 1034020 (50 mg/25 mL - iv) |
Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning. |
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Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
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