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Safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655064 after single rising doses in healthy Asian male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 655064 dose group 1 - 80 mg | Experimental |
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| BI 655064 dose group 2 - 120 mg | Experimental |
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| BI 655064 dose group 3 - 180 mg | Experimental |
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| BI 655064 dose group 4 - 240 mg | Experimental |
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| Placebo matching BI 655064 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Solution for subcutaneous (s.c.) injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Investigator Defined Drug-related Adverse Events | Number of participants with investigator defined drug-related adverse events (AEs) is reported. | From study drug administration until end-of-study examination, up to 77 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measured Concentration of BI 655064 in Plasma (Cmax) | Maximum measured concentration of BI 655064 in plasma (Cmax) is reported. | Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration. |
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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 |
|---|---|---|---|---|---|---|
| 1293.8.8101 Boehringer Ingelheim Investigational Site | Sumida-ku,Tokyo | Japan | ||||
| 1293.8.8201 Boehringer Ingelheim Investigational Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
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All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This was a randomised, placebo-controlled, double-blind within dose groups, single rising dose study with 4 doses in Chinese and Japanese healthy volunteers.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 655064 Dose Group 1 - 80 mg | Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 80 milligram (mg) of solution for injection of BI 655064. |
| FG001 | BI 655064 Dose Group 2 - 120 mg | Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 120 milligram (mg) of solution for injection of BI 655064. |
| FG002 | BI 655064 Dose Group 3 - 180 mg | Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 180 milligram (mg) of solution for injection of BI 655064. |
| FG003 | BI 655064 Dose Group 4 - 240 mg | Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 240 milligram (mg) of solution for injection of BI 655064. |
| FG004 | Placebo Matching BI 655064 | Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of solution for injection of Placebo matching BI 655064. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Treated Set (TS): This subject set included all subjects who were documented to have taken study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 655064 Dose Group 1 - 80 mg | Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 80 milligram (mg) of solution for injection of BI 655064. |
| BG001 | BI 655064 Dose Group 2 - 120 mg |
| 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 |
| 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 | Number of Participants With Investigator Defined Drug-related Adverse Events | Number of participants with investigator defined drug-related adverse events (AEs) is reported. | Treated Set (TS): This subject set included all subjects who were documented to have taken study medication. | Posted | Count of Participants | Participants | From study drug administration until end-of-study examination, up to 77 days. |
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From study drug administration until end-of-study examination, up to 77 days.
Treated Set (TS): This subject set included all subjects who were documented to have taken study medication.
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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 655064 Dose Group 1 - 80 mg | Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 80 milligram (mg) of solution for injection of BI 655064. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | 17.0 | 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 |
|---|---|
| C000627991 | BI 655064 |
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| BI 655064 |
| Drug |
Solution for subcutaneous (s.c.) injection. |
|
| Area Under the Concentration-time Curve of the Analyte BI 655064 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the analyte BI 655064 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. | Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration. |
| Area Under the Concentration-time Curve of the Analyte BI 655064 in the Plasma Over the Time Interval From 0 to the Last Measurable Time Point (AUC0-tz) | Area under the concentration-time curve of the analyte BI 655064 in the plasma over the time interval from 0 to the last measurable time point (AUC0-tz) is reported. | Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration. |
| Seoul |
| South Korea |
Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 120 milligram (mg) of solution for injection of BI 655064.
| BG002 | BI 655064 Dose Group 3 - 180 mg | Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 180 milligram (mg) of solution for injection of BI 655064. |
| BG003 | BI 655064 Dose Group 4 - 240 mg | Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 240 milligram (mg) of solution for injection of BI 655064. |
| BG004 | Placebo Matching BI 655064 | Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of solution for injection of Placebo matching BI 655064. |
| BG005 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 120 milligram (mg) of solution for injection of BI 655064.
| OG002 | BI 655064 Dose Group 3 - 180 mg | Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 180 milligram (mg) of solution for injection of BI 655064. |
| OG003 | BI 655064 Dose Group 4 - 240 mg | Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 240 milligram (mg) of solution for injection of BI 655064. |
| OG004 | Placebo Matching BI 655064 | Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of solution for injection of Placebo matching BI 655064. |
|
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| Secondary | Maximum Measured Concentration of BI 655064 in Plasma (Cmax) | Maximum measured concentration of BI 655064 in plasma (Cmax) is reported. | The pharmacokinetic (PK) set (PKS) included all subjects from the treated set (TS) who provided at least 1 secondary PK endpoint that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints. Only participants with evaluable results for this PK parameter are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram (ng)/ (milliliter) mL | Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration. |
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| Secondary | Area Under the Concentration-time Curve of the Analyte BI 655064 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the analyte BI 655064 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. | The pharmacokinetic (PK) set (PKS) included all subjects from the treated (TS) who provided at least 1 secondary PK endpoint that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints. Only participants with evaluable results for this PK parameter are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram (µg)*hours (h)/mL | Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration. |
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| Secondary | Area Under the Concentration-time Curve of the Analyte BI 655064 in the Plasma Over the Time Interval From 0 to the Last Measurable Time Point (AUC0-tz) | Area under the concentration-time curve of the analyte BI 655064 in the plasma over the time interval from 0 to the last measurable time point (AUC0-tz) is reported. | The pharmacokinetic (PK) set (PKS) included all subjects from the treated set (TS) who provided at least 1 secondary PK endpoint that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints. Only participants with evaluable results for this PK parameter are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram (µg)*hours (h)/mL | Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration. |
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| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | BI 655064 Dose Group 2 - 120 mg | Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 120 milligram (mg) of solution for injection of BI 655064. | 0 | 12 | 3 | 12 |
| EG002 | BI 655064 Dose Group 3 - 180 mg | Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 180 milligram (mg) of solution for injection of BI 655064. | 0 | 12 | 5 | 12 |
| EG003 | BI 655064 Dose Group 4 - 240 mg | Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 240 milligram (mg) of solution for injection of BI 655064. | 0 | 12 | 4 | 12 |
| EG004 | Placebo Matching BI 655064 | Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of solution for injection of Placebo matching BI 655064. | 0 | 16 | 5 | 16 |
| Decreased appetite | Metabolism and nutrition disorders | 17.0 | Systematic Assessment |
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| Headache | Nervous system disorders | 17.0 | Systematic Assessment |
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| Tension headache | Nervous system disorders | 17.0 | Systematic Assessment |
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| Motion sickness | Ear and labyrinth disorders | 17.0 | Systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | 17.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | 17.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 17.0 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | 17.0 | Systematic Assessment |
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| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | 17.0 | Systematic Assessment |
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| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | 17.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | 17.0 | Systematic Assessment |
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| Gingival bleeding | Gastrointestinal disorders | 17.0 | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | 17.0 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | 17.0 | Systematic Assessment |
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| Pain of skin | Skin and subcutaneous tissue disorders | 17.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | 17.0 | Systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | 17.0 | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | 17.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | 17.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | 17.0 | Systematic Assessment |
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| Tendonitis | Musculoskeletal and connective tissue disorders | 17.0 | Systematic Assessment |
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| Administration site rash | General disorders | 17.0 | Systematic Assessment |
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| Fatigue | General disorders | 17.0 | Systematic Assessment |
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| Feeling cold | General disorders | 17.0 | Systematic Assessment |
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| Feeling hot | General disorders | 17.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | 17.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | 17.0 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | 17.0 | 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.
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| Japanese participants |
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| Japanese participants |
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| Japanese participants |
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