Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002413-29 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Investigation of safety and tolerability of BI 655088 following intravenous infusion of single rising doses and exploration of the pharmacokinetics and pharmacodynamics of BI 655088 after single dosing
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 655088 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 655088 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Drug-related Adverse Events | The number of subjects with drug-related adverse events. | up to 99 days after start of drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measured Concentration of BI 655088 in Plasma (Cmax) | Maximum measured concentration of BI 655088 in plasma (Cmax). Time frame for all dose groups: within 3 hours before and 10, 24, 36, 48, 72, 96, 120, 144, 168, 264, 336, 432, 504, 600, 672, 840, 1008, 1176, 1344, 1512, 1680 and 2016 hours following start of infusion. In additional, the following time points for the 2 milligram group: 0.25, 0.5, 1, 1.5, 2.25, 2.5, 3, 6, 8, 12 and 30 hours following start of infusion. |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Life Science Services - Clinical Research | Edegem | 2650 | Belgium |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that the subjects met all strictly implemented inclusion and none of the exclusion criteria. Subjects would not have been treated with the trial treatment if any one of the specific entry criteria had been violated.
Single-rising dose trial, partially randomised within dose groups, placebo-controlled, single-blind, parallel-group design with 6 dose groups.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Comparator product: Matching Placebo to BI 655088 (buffer solution). Mode of administration: Intravenous (IV) infusion for 120 minutes |
| FG001 | BI 655088 2 mg | BI investigational product: Single Dose of 2 milligram (mg) of BI 655088 as solution for infusion (10 mg/millilitre (mL) in buffer solution). Mode of administration: IV infusion for 120 minutes |
| FG002 | BI 655088 6 mg | BI investigational product: Single Dose of 6mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes |
| FG003 | BI 655088 20 mg | BI investigational product: Single Dose of 20mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes |
| FG004 | BI 655088 50 mg | BI investigational product: Single Dose of 50mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes |
| FG005 | BI 655088 100 mg | BI investigational product: Single Dose of 100mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes |
| FG006 | BI 655088 200 mg | BI investigational product: Single Dose of 200mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set:
This subject set included all subjects who were documented to have received at least
1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, and disposition.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Comparator product: Matching Placebo to BI 655088 (buffer solution). Mode of administration: Intravenous (IV) infusion for 120 minutes |
| BG001 | BI 655088 2 mg | BI investigational product: Single Dose of 2 milligram (mg) of BI 655088 as solution for infusion (10 mg/millilitre (mL) in buffer solution). Mode of administration: IV infusion for 120 minutes |
| 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 | Number of Subjects With Drug-related Adverse Events | The number of subjects with drug-related adverse events. | Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug. It was used for analysis of safety, demographic data, and baseline characteristics, and disposition. | Posted | Number | Participants | up to 99 days after start of drug administration |
|
from individual subjects' drug administration until individual subjects' end of trial ,up to 99 days
Treated set: This subject set included all subjects who were documented to have received at least 1 dose of trial drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Comparator product: Matching Placebo to BI 655088 (buffer solution). Mode of administration: Intravenous (IV) infusion for 120 minutes |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 22, 2017 | Mar 28, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2019 | Mar 28, 2022 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Up to 2016 hours. See endpoint description for a detailed timeframe. |
| Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | AUC0-tz (area under the concentration-time curve of BI 655088 in plasma over the time interval from 0 to the last quantifiable data point). Time frame for all dose groups: within 3 hours before and 10, 24, 36, 48, 72, 96, 120, 144, 168, 264, 336, 432, 504, 600, 672, 840, 1008, 1176, 1344, 1512, 1680 and 2016 hours following start of infusion. In additional, the following time points for the 2 milligram group: 0.25, 0.5, 1, 1.5, 2.25, 2.5, 3, 6, 8, 12 and 30 hours following start of infusion. | Up to 2016 hours. See endpoint description for a detailed timeframe. |
| Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) | AUC0-∞ (area under the concentration-time curve of BI 655088 in plasma over the time interval from 0 extrapolated to infinity). Time frame for all dose groups: within 3 hours before and 10, 24, 36, 48, 72, 96, 120, 144, 168, 264, 336, 432, 504, 600, 672, 840, 1008, 1176, 1344, 1512, 1680 and 2016 hours following start of infusion. In additional, the following time points for the 2 milligram group: 0.25, 0.5, 1, 1.5, 2.25, 2.5, 3, 6, 8, 12 and 30 hours following start of infusion. | Up to 2016 hours. See endpoint description for a detailed timeframe. |
| BG002 | BI 655088 6 mg | BI investigational product: Single Dose of 6mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes |
| BG003 | BI 655088 20 mg | BI investigational product: Single Dose of 20mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes |
| BG004 | BI 655088 50 mg | BI investigational product: Single Dose of 50mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes |
| BG005 | BI 655088 100 mg | BI investigational product: Single Dose of 100mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes |
| BG006 | BI 655088 200 mg | BI investigational product: Single Dose of 200mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | BI 655088 6 mg | BI investigational product: Single Dose of 6mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes |
| OG003 | BI 655088 20 mg | BI investigational product: Single Dose of 20mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes |
| OG004 | BI 655088 50 mg | BI investigational product: Single Dose of 50mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes |
| OG005 | BI 655088 100 mg | BI investigational product: Single Dose of 100mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes |
| OG006 | BI 655088 200 mg | BI investigational product: Single Dose of 200mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes |
|
|
| Secondary | Maximum Measured Concentration of BI 655088 in Plasma (Cmax) | Maximum measured concentration of BI 655088 in plasma (Cmax). Time frame for all dose groups: within 3 hours before and 10, 24, 36, 48, 72, 96, 120, 144, 168, 264, 336, 432, 504, 600, 672, 840, 1008, 1176, 1344, 1512, 1680 and 2016 hours following start of infusion. In additional, the following time points for the 2 milligram group: 0.25, 0.5, 1, 1.5, 2.25, 2.5, 3, 6, 8, 12 and 30 hours following start of infusion. | Pharmacokinetic (PK) parameter analysis set: This subject set included all subjects who were documented to have received at least 1 dose of BI 655088 and who provided at least 1 PK endpoint value that was not excluded (due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability). | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram (µg) / millilitre (mL) | Up to 2016 hours. See endpoint description for a detailed timeframe. |
|
|
|
| Secondary | Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | AUC0-tz (area under the concentration-time curve of BI 655088 in plasma over the time interval from 0 to the last quantifiable data point). Time frame for all dose groups: within 3 hours before and 10, 24, 36, 48, 72, 96, 120, 144, 168, 264, 336, 432, 504, 600, 672, 840, 1008, 1176, 1344, 1512, 1680 and 2016 hours following start of infusion. In additional, the following time points for the 2 milligram group: 0.25, 0.5, 1, 1.5, 2.25, 2.5, 3, 6, 8, 12 and 30 hours following start of infusion. | Pharmacokinetic (PK) parameter analysis set: This subject set included all subjects who were documented to have received at least 1 dose of BI 655088 and who provided at least 1 PK endpoint value that was not excluded (due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability). 1 subject was excluded from the 200 mg group due to missing samples after 840 hours. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram (µg)∙hour (h)/millilitre (mL) | Up to 2016 hours. See endpoint description for a detailed timeframe. |
|
|
|
| Secondary | Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) | AUC0-∞ (area under the concentration-time curve of BI 655088 in plasma over the time interval from 0 extrapolated to infinity). Time frame for all dose groups: within 3 hours before and 10, 24, 36, 48, 72, 96, 120, 144, 168, 264, 336, 432, 504, 600, 672, 840, 1008, 1176, 1344, 1512, 1680 and 2016 hours following start of infusion. In additional, the following time points for the 2 milligram group: 0.25, 0.5, 1, 1.5, 2.25, 2.5, 3, 6, 8, 12 and 30 hours following start of infusion. | Pharmacokinetic (PK) parameter analysis set: This subject set included all subjects who were documented to have received at least 1 dose of BI 655088 and who provided at least 1 PK endpoint value that was not excluded (due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability). | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram (µg)∙hour (h) /millilitre(mL) | Up to 2016 hours. See endpoint description for a detailed timeframe. |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 10 |
| 12 |
| EG001 | 2 mg BI | BI investigational product: Single Dose of 2 milligram (mg) of BI 655088 as solution for infusion (10 mg/millilitre (mL) in buffer solution). Mode of administration: IV infusion for 120 minutes | 0 | 5 | 1 | 5 | 4 | 5 |
| EG002 | 6 mg BI | BI investigational product: Single Dose of 6mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | 20 mg BI | BI investigational product: Single Dose of 20mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes | 0 | 6 | 0 | 6 | 2 | 6 |
| EG004 | 50 mg BI | BI investigational product: Single Dose of 50mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes | 0 | 6 | 0 | 6 | 1 | 6 |
| EG005 | 100 mg BI | BI investigational product: Single Dose of 100mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes | 0 | 6 | 0 | 6 | 2 | 6 |
| EG006 | 200 mg BI | BI investigational product: Single Dose of 200mg of BI 655088 as solution for infusion (10 mg/mL in buffer solution). Mode of administration: IV infusion for 120 minutes | 0 | 6 | 1 | 6 | 3 | 6 |
| Hepatic failure | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pathogen resistance | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Application site irritation | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Laboratory test abnormal | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Skin wound | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Eye injury | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA 21.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 21.1 | 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.