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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003389-42 | EudraCT Number |
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Due to the COVID-19 pandemic, the recruitment of new subjects was temporarily halted in March 2020. The study was permanently discontinued in December 2020.
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To investigate rates and routes of excretion, mass balance, pharmacokinetics of parent drug, any known metabolites, and total radioactivity, metabolite profiling, metabolite identification, if suitable assays are available, safety and tolerability in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: BI 1265162 - intravenous | Experimental |
| |
| Part 2: BI 1265162 - oral | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Part 1: BI 1265162 - intravenous | Drug | Intravenous solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Mass Balance Recovery of Total (C-14) BI 1265162-radioactivity in Urine | Mass balance recovery assessed as amount of (C-14) BI 1265162-radioactivity excreted as a percentage of the single intravenous administered dose of BI 1265162 (C-14) over the time interval from 0 to 192 hours. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. | On Day -1 or Day 1 pre-dose (blank) sample, on Day 1 prior to start of urine collection voiding of the bladder, 0-4 , 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, and 168-192 hours after administration of BI 1265162 (C-14). |
| Part 1: Mass Balance Recovery of Total (C-14) BI 1265162-radioactivity in Faeces. | Mass balance recovery assessed as amount of (C-14) BI 1265162-radioactivity excreted as a percentage of the single intravenous administered dose of BI 1265162 (C-14) over the time interval from 0 to 192 hours. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. | On Day -2, Day -1 or Day 1 pre-dose (blank) sample, and on Day 1 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, and 168-192 hours after administration of BI 1265162 (C-14). |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Area Under the Concentration-time Curve of Total [14C]BI 1265162-equivalent (EQ) in Plasma Over the Time Interval From 0 to 192 Hours (the Last Quantifiable Data Point (AUC0-tz)) | Area under the concentration-time curve of total [14C]BI 1265162-EQ in plasma over the time interval from 0 to 192 hours (the last quantifiable data point (AUC0-tz)) was analyzed after the single intravenous dose administration of BI 1265162 (C-14). Plasma concentrations of (C-14) BI 1265162-radioactivity are expressed as [14C]BI 1265162-EQ. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. |
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Inclusion criteria
Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocrdiogram (ECG), and clinical laboratory tests
Age of 18 to 65 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation
Subjects who are sexually active must use, with their partner, highly effective contraception from the time of administration of trial medication until 3 months after administration of trial medication. Adequate methods are:
Alternatively, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle. If a subject is usually not sexually active but becomes active, with their partner, they must comply with the contraceptive requirements detailed above.
Exclusion criteria
In addition, the following trial-specific exclusion criteria apply:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences Onderzoekscentrum Martini | Groningen | 9728 NZ | Netherlands |
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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, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).
For more details refer to: http://trials.boehringer-ingelheim.com/
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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 non-randomised, open-label, single-dose, single arm, mass balance trial in healthy male subjects.
The trial had 2 parts. Part 1 was investigating metabolism and pharmacokinetics of (C-14 (radiocarbon labelled)) BI 1265162 after intravenous administration.
Part 2 was investigating metabolism and pharmacokinetics of (C-14) BI 1265162 after oral administration.
Part 2 was not conducted due to premature discontinuation of the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 1265162 - Intravenous | Participants received a single intravenous infusion (i.v.) of 50 microgram (μg) of BI 1265162, consisting of 45 μg unlabeled BI 1265162 mixed with 5 μg Carbon 14 labelled BI 1265162 ([14C]BI 1265162) (radocarbon as 10 milliliter (mL) in i.v. solution (5 μg BI 1265162 (C-14)/mL) over 1 hour (h) was administered after an overnight fast of at least 10 h. The radioactive dose per infusion was calculated to not exceed 0.018 megabecquerel (MBq). Participants received 240 mL of fluid 1 h and 4 h after administration. Participants also received lunch 4 h after administration. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated set (TS): The treated set includes all participants who were entered and treated with one dose of trial drug. The treated set will be used for safety analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 1265162 - Intravenous | Participants received a single intravenous infusion (i.v.) of 50 microgram (μg) of BI 1265162, consisting of 45 μg unlabeled BI 1265162 mixed with 5 μg Carbon 14 labelled BI 1265162 ([14C]BI 1265162) (radocarbon as 10 milliliter (mL) in i.v. solution (5 μg BI 1265162 (C-14)/mL) over 1 hour (h) was administered after an overnight fast of at least 10 h. The radioactive dose per infusion was calculated to not exceed 0.018 megabecquerel (MBq). Participants received 240 mL of fluid 1 h and 4 h after administration. Participants also received lunch 4 h after administration. |
| 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 | Part 1: Mass Balance Recovery of Total (C-14) BI 1265162-radioactivity in Urine | Mass balance recovery assessed as amount of (C-14) BI 1265162-radioactivity excreted as a percentage of the single intravenous administered dose of BI 1265162 (C-14) over the time interval from 0 to 192 hours. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. | Pharmacokinetic parameter analysis set (PKS): This set includes all participants from the treated set (TS) who provide at least one pharmacokinetic endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetics or due to pharmacokinetic non-evaluability (as specified in the following subsection 'Pharmacokinetics'). Descriptive analyses of pharmacokinetic parameters will be based on the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of the administered dose | On Day -1 or Day 1 pre-dose (blank) sample, on Day 1 prior to start of urine collection voiding of the bladder, 0-4 , 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, and 168-192 hours after administration of BI 1265162 (C-14). |
From drug administration up to 22 days.
Treated set (TS): The treated set includes all participants who were entered and treated with one dose of trial drug. The treated set will be used for safety analyses.
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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 1265162 - Intravenous | Participants received a single intravenous infusion (i.v.) of 50 microgram (μg) of BI 1265162, consisting of 45 μg unlabeled BI 1265162 mixed with 5 μg Carbon 14 labelled BI 1265162 ([14C]BI 1265162) (radocarbon as 10 milliliter (mL) in i.v. solution (5 μg BI 1265162 (C-14)/mL) over 1 hour (h) was administered after an overnight fast of at least 10 h. The radioactive dose per infusion was calculated to not exceed 0.018 megabecquerel (MBq). Participants received 240 mL of fluid 1 h and 4 h after administration. Participants also received lunch 4 h after administration. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toothache | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
The study was interrupted due to COVID-19 crisis on 02-Apr-2020, after completion of Part 1. Further, the sponsor decided to discontinue the development of BI 1265162. Enrolment in Part 2 (oral administration of BI 1265162 (C-14)) did not take place. Decision to terminate trial was taken on 17-Dec-2020.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 25, 2020 | Dec 17, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 18, 2021 | Dec 17, 2021 | SAP_001.pdf |
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| Part 2: BI 1265162 - oral |
| Drug |
Oral solution |
|
| At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14). |
| Part 1: Area Under the Concentration-time Curve of Total BI 1265162 in Plasma Over the Time Interval From 0 to 192 Hours (the Last Quantifiable Data Point (AUC0-tz)) | Area under the concentration-time curve of total BI 1265162 in plasma over the time interval from 0 to 192 hours (the last quantifiable data point (AUC0-tz)) was analyzed after the single intravenous dose administration. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. | At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14). |
| Part 1: Area Under the Concentration-time Curve of Total BI 1265162 Metabolite M582 in Plasma Over the Time Interval From 0 to 192 Hours (the Last Quantifiable Data Point (AUC0-tz)) | Area under the concentration-time curve of total BI 1265162 metabolite M582 in plasma over the time interval from 0 to 192 hours (the last quantifiable data point (AUC0-tz)) was analyzed after the single intravenous dose administration. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. | At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14). |
| Part 1: Maximum Measured Concentration (Cmax) of Total [14C]BI 1265162-equivalent (EQ) in Plasma | Maximum measured concentration (Cmax) of total [14C]BI 1265162-EQ in plasma was analyzed after the single intravenous dose administration. Plasma concentrations of (C-14) BI 1265162-radioactivity are expressed as [14C]BI 1265162-EQ (EQ: equivalent). The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. | At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14). |
| Part 1: Maximum Measured Concentration (Cmax) of Total BI 1265162 in Plasma | Maximum measured concentration (Cmax) of total BI 1265162 in plasma was analyzed after the single intravenous dose administration. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. | At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14). |
| Part 1: Maximum Measured Concentration (Cmax) of Total BI 1265162 Metabolite M582 in Plasma | Maximum measured concentration (Cmax) of total metabolite M582 in plasma was analyzed after single dose administration. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. | At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14). |
| Part 1: Percentage of Participants With Drug Related Adverse Events (AEs) Including Clinically Relevant Findings From the Physical Examination | Percentage of participants with drug related adverse events (AEs) including clinically relevant findings from the physical examination. Percentages are calculated using total number of participants per treatment as the denominator. | From drug administration up to 22 days. |
| Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | BI 1265162 - Intravenous | Participants received a single intravenous infusion (i.v.) of 50 microgram (μg) of BI 1265162, consisting of 45 μg unlabeled BI 1265162 mixed with 5 μg Carbon 14 labelled BI 1265162 ([14C]BI 1265162) (radocarbon as 10 milliliter (mL) in i.v. solution (5 μg BI 1265162 (C-14)/mL) over 1 hour (h) was administered after an overnight fast of at least 10 h. The radioactive dose per infusion was calculated to not exceed 0.018 megabecquerel (MBq). Participants received 240 mL of fluid 1 h and 4 h after administration. Participants also received lunch 4 h after administration. |
|
|
| Primary | Part 1: Mass Balance Recovery of Total (C-14) BI 1265162-radioactivity in Faeces. | Mass balance recovery assessed as amount of (C-14) BI 1265162-radioactivity excreted as a percentage of the single intravenous administered dose of BI 1265162 (C-14) over the time interval from 0 to 192 hours. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. | Pharmacokinetic parameter analysis set (PKS): This set includes all participants from the treated set (TS) who provide at least one pharmacokinetic endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetics or due to pharmacokinetic non-evaluability (as specified in the following subsection 'Pharmacokinetics'). Descriptive analyses of pharmacokinetic parameters will be based on the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of the administered dose | On Day -2, Day -1 or Day 1 pre-dose (blank) sample, and on Day 1 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, and 168-192 hours after administration of BI 1265162 (C-14). |
|
|
|
| Secondary | Part 1: Area Under the Concentration-time Curve of Total [14C]BI 1265162-equivalent (EQ) in Plasma Over the Time Interval From 0 to 192 Hours (the Last Quantifiable Data Point (AUC0-tz)) | Area under the concentration-time curve of total [14C]BI 1265162-EQ in plasma over the time interval from 0 to 192 hours (the last quantifiable data point (AUC0-tz)) was analyzed after the single intravenous dose administration of BI 1265162 (C-14). Plasma concentrations of (C-14) BI 1265162-radioactivity are expressed as [14C]BI 1265162-EQ. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. | Pharmacokinetic parameter analysis set (PKS): This set includes all participants from the treated set (TS) who provide at least one pharmacokinetic endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetics or due to pharmacokinetic non-evaluability (as specified in the following subsection 'Pharmacokinetics'). Descriptive analyses of pharmacokinetic parameters will be based on the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour times picomole per litre | At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14). |
|
|
|
| Secondary | Part 1: Area Under the Concentration-time Curve of Total BI 1265162 in Plasma Over the Time Interval From 0 to 192 Hours (the Last Quantifiable Data Point (AUC0-tz)) | Area under the concentration-time curve of total BI 1265162 in plasma over the time interval from 0 to 192 hours (the last quantifiable data point (AUC0-tz)) was analyzed after the single intravenous dose administration. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. | Pharmacokinetic parameter analysis set (PKS): This set includes all participants from the treated set (TS) who provide at least one pharmacokinetic endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetics or due to pharmacokinetic non-evaluability (as specified in the following subsection 'Pharmacokinetics'). Descriptive analyses of pharmacokinetic parameters will be based on the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour times picomole per litre | At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14). |
|
|
|
| Secondary | Part 1: Area Under the Concentration-time Curve of Total BI 1265162 Metabolite M582 in Plasma Over the Time Interval From 0 to 192 Hours (the Last Quantifiable Data Point (AUC0-tz)) | Area under the concentration-time curve of total BI 1265162 metabolite M582 in plasma over the time interval from 0 to 192 hours (the last quantifiable data point (AUC0-tz)) was analyzed after the single intravenous dose administration. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. | Pharmacokinetic parameter analysis set (PKS): This set includes all participants from the treated set (TS) who provide at least one pharmacokinetic endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetics or due to pharmacokinetic non-evaluability (as specified in the following subsection 'Pharmacokinetics'). Descriptive analyses of pharmacokinetic parameters will be based on the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour times picomole per litre | At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14). |
|
|
|
| Secondary | Part 1: Maximum Measured Concentration (Cmax) of Total [14C]BI 1265162-equivalent (EQ) in Plasma | Maximum measured concentration (Cmax) of total [14C]BI 1265162-EQ in plasma was analyzed after the single intravenous dose administration. Plasma concentrations of (C-14) BI 1265162-radioactivity are expressed as [14C]BI 1265162-EQ (EQ: equivalent). The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. | Pharmacokinetic parameter analysis set (PKS): This set includes all participants from the treated set (TS) who provide at least one pharmacokinetic endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetics or due to pharmacokinetic non-evaluability (as specified in the following subsection 'Pharmacokinetics'). Descriptive analyses of pharmacokinetic parameters will be based on the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | Picomole per litre | At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14). |
|
|
|
| Secondary | Part 1: Maximum Measured Concentration (Cmax) of Total BI 1265162 in Plasma | Maximum measured concentration (Cmax) of total BI 1265162 in plasma was analyzed after the single intravenous dose administration. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. | Pharmacokinetic parameter analysis set (PKS): This set includes all participants from the treated set (TS) who provide at least one pharmacokinetic endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetics or due to pharmacokinetic non-evaluability (as specified in the following subsection 'Pharmacokinetics'). Descriptive analyses of pharmacokinetic parameters will be based on the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | Picomole per litre | At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14). |
|
|
|
| Secondary | Part 1: Maximum Measured Concentration (Cmax) of Total BI 1265162 Metabolite M582 in Plasma | Maximum measured concentration (Cmax) of total metabolite M582 in plasma was analyzed after single dose administration. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. | Pharmacokinetic parameter analysis set (PKS): This set includes all participants from the treated set (TS) who provide at least one pharmacokinetic endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetics or due to pharmacokinetic non-evaluability (as specified in the following subsection 'Pharmacokinetics'). Descriptive analyses of pharmacokinetic parameters will be based on the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | Picomole per litre | At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14). |
|
|
|
| Secondary | Part 1: Percentage of Participants With Drug Related Adverse Events (AEs) Including Clinically Relevant Findings From the Physical Examination | Percentage of participants with drug related adverse events (AEs) including clinically relevant findings from the physical examination. Percentages are calculated using total number of participants per treatment as the denominator. | Treated set (TS): The treated set includes all participants who were entered and treated with one dose of trial drug. The treated set will be used for safety analyses. | Posted | Number | Percentage of participants | From drug administration up to 22 days. |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 4 |
| 7 |
| Dysgeusia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | 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.