Healthy
Conditions
Brief summary
The primary objective of this trial is to investigate the relative bioavailability of BI 655130 administered as two subcutaneous injections in the left and right periumbilical region compared to a single subcutaneous periumbilical injection of BI 655130. The secondary objective is to investigate the relative bioavailability of a single subcutaneous injection of BI 655130 into the thigh compared to a single subcutaneous periumbilical injection of BI 655130.
Interventions
DRUGR - Low dose of BI 655130
Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the periumbilical region following an overnight fast of at least 10 hours.
DRUGT1 - Low dose of BI 655130
Single low dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 1 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.
DRUGT2 - Low dose of BI 655130
Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the thigh region following an overnight fast of at least 10 hours.
DRUGT3 - High dose of BI 655130
Single high dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 2 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
- Healthy male or female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests * Age of 18 to 50 years (incl.) * Body mass index (BMI) of 19.0 to 29.9 kg/m2 (incl.) * Signed and dated written informed consent prior to admission to the study in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation * Male subjects, or female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion: * Use of adequate contraception, e.g. any of the following methods plus condom: ---implants, injectables, combined oral or vaginal contraceptives, intrauterine device * Sexually abstinent * A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment) * Surgically sterilised (including hysterectomy) * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 IU/L and estradiol below 30 ng/L is confirmatory)
Exclusion criteria
* Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator * Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm) * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance * Any evidence of a concomitant disease judged as clinically relevant by the investigator * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders * History of relevant orthostatic hypotension, fainting spells, or blackouts * Chronic or relevant acute infections * History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients) * Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation) * Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug * Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day) * Inability to refrain from smoking on specified trial days * Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males) * Drug abuse or positive drug screening * Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial * Intention to perform excessive physical activities within one week prior to administration of trial medication up to 4 weeks after administration * Inability to comply with dietary regimen of trial site * A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening * A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome) * Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study Female subjects will not be allowed to participate if any of the following applies: * Positive pregnancy test, pregnancy or plans to become pregnant up to study completion * Lactation In addition, the following trial-specific exclusion criterion applies: \- Previous use of the trial medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug. | Area under the concentration-time curve of BI 655130 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Participants assigned to the Test Treatment Groups T1 and T2 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R. |
| Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz), Dose-Normalized | Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug. | Area under the concentration-time curve of BI 655130 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), dose-normalized. Participants assigned to the Test Treatment Group T3 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R. mL = milliliter, mg = milligram. |
| Maximum Measured Concentration of BI 655130 in Plasma (Cmax) | Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug. | Maximum measured concentration of BI 655130 in plasma (Cmax). Participants assigned to the Test Treatment Groups T1 and T2 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R. |
| Maximum Measured Concentration of BI 655130 in Plasma (Cmax), Dose-Normalized | Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug. | Maximum measured concentration of BI 655130 in plasma (Cmax), dose-normalized. Participants assigned to the Test Treatment Group T3 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug. | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Participants assigned to the Test Treatment Groups T1 and T2 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R. |
| Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞), Dose-Normalized | Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug. | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), dose-normalized. Participants assigned to the Test Treatment Group T3 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R. mL = milliliter, mg = milligram. |
Countries
Belgium
Participant flow
Recruitment details
A single dose, mono-centric, open-label study in matched-group design, that is, subjects assigned to the 3 test treatment groups were matched on an individual level for gender and body weight to subjects assigned to the reference treatment group.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| R - Low Dose of BI 655130 Periumbilical Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the periumbilical region following an overnight fast of at least 10 hours. | 12 |
| T1 - Low Dose of BI 655130 Periumbilical (Left and Right) Single low dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 1 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours. | 12 |
| T2 - Low Dose of BI 655130 Thigh Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the thigh region following an overnight fast of at least 10 hours. | 12 |
| T3 - High Dose of BI 655130 Periumbilical (Left and Right) Single high dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 2 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours. | 12 |
| Total | 48 |
Baseline characteristics
| Characteristic | R - Low Dose of BI 655130 Periumbilical | T1 - Low Dose of BI 655130 Periumbilical (Left and Right) | T2 - Low Dose of BI 655130 Thigh | T3 - High Dose of BI 655130 Periumbilical (Left and Right) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 33.2 years STANDARD_DEVIATION 9.5 | 37.1 years STANDARD_DEVIATION 5.7 | 37.4 years STANDARD_DEVIATION 7.5 | 35.2 years STANDARD_DEVIATION 9.2 | 35.7 years STANDARD_DEVIATION 8.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 12 Participants | 12 Participants | 12 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 11 Participants | 12 Participants | 12 Participants | 46 Participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 40 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 11 / 12 | 11 / 12 | 10 / 12 | 11 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of BI 655130 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Participants assigned to the Test Treatment Groups T1 and T2 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.
Time frame: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.
Population: Pharmacokinetic (PK) parameter set: all participants in the Treated set (all participants who received at least one dose of study drug) who provided at least one primary or secondary PK parameter that was not excluded because of important protocol deviations relevant to the statistical evaluation of PK endpoints or because of non-evaluability.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| R - Low Dose of BI 655130 Periumbilical | Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | 1227.91 day * microgram / milliliter |
| T1 - Low Dose of BI 655130 Periumbilical (Left and Right) | Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | 1150.18 day * microgram / milliliter |
| T2 - Low Dose of BI 655130 Thigh | Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | 1718.47 day * microgram / milliliter |
Comparison: Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.90% CI: [78.48, 111.8]
Comparison: Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.90% CI: [117.26, 167.03]
Primary
Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz), Dose-Normalized
Area under the concentration-time curve of BI 655130 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), dose-normalized. Participants assigned to the Test Treatment Group T3 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R. mL = milliliter, mg = milligram.
Time frame: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.
Population: Pharmacokinetic (PK) parameter set: all participants in the Treated set (all participants who received at least one dose of study drug) who provided at least one primary or secondary PK parameter that was not excluded because of important protocol deviations relevant to the statistical evaluation of PK endpoints or because of non-evaluability.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| R - Low Dose of BI 655130 Periumbilical | Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz), Dose-Normalized | 4.09 day * microgram * (1 / mL) * (1 / mg) |
| T1 - Low Dose of BI 655130 Periumbilical (Left and Right) | Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz), Dose-Normalized | 4.99 day * microgram * (1 / mL) * (1 / mg) |
Comparison: Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.90% CI: [102.08, 145.41]
Primary
Maximum Measured Concentration of BI 655130 in Plasma (Cmax)
Maximum measured concentration of BI 655130 in plasma (Cmax). Participants assigned to the Test Treatment Groups T1 and T2 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.
Time frame: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.
Population: Pharmacokinetic (PK) parameter set: all participants in the Treated set (all participants who received at least one dose of study drug) who provided at least one primary or secondary PK parameter that was not excluded because of important protocol deviations relevant to the statistical evaluation of PK endpoints or because of non-evaluability.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| R - Low Dose of BI 655130 Periumbilical | Maximum Measured Concentration of BI 655130 in Plasma (Cmax) | 24.56 microgram / milliliter |
| T1 - Low Dose of BI 655130 Periumbilical (Left and Right) | Maximum Measured Concentration of BI 655130 in Plasma (Cmax) | 24.35 microgram / milliliter |
| T2 - Low Dose of BI 655130 Thigh | Maximum Measured Concentration of BI 655130 in Plasma (Cmax) | 38.36 microgram / milliliter |
Comparison: Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.90% CI: [83.77, 117.39]
Comparison: Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.90% CI: [131.95, 184.9]
Primary
Maximum Measured Concentration of BI 655130 in Plasma (Cmax), Dose-Normalized
Maximum measured concentration of BI 655130 in plasma (Cmax), dose-normalized. Participants assigned to the Test Treatment Group T3 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.
Time frame: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.
Population: Pharmacokinetic (PK) parameter set: all participants in the Treated set (all participants who received at least one dose of study drug) who provided at least one primary or secondary PK parameter that was not excluded because of important protocol deviations relevant to the statistical evaluation of PK endpoints or because of non-evaluability.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| R - Low Dose of BI 655130 Periumbilical | Maximum Measured Concentration of BI 655130 in Plasma (Cmax), Dose-Normalized | 0.08 (microgram / milliliter) / milligram |
| T1 - Low Dose of BI 655130 Periumbilical (Left and Right) | Maximum Measured Concentration of BI 655130 in Plasma (Cmax), Dose-Normalized | 0.11 (microgram / milliliter) / milligram |
Comparison: Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.90% CI: [116.87, 163.77]
Secondary
Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Participants assigned to the Test Treatment Groups T1 and T2 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.
Time frame: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.
Population: Pharmacokinetic (PK) parameter set: all participants in the Treated set (all participants who received at least one dose of study drug) who provided at least one primary or secondary PK parameter that was not excluded because of important protocol deviations relevant to the statistical evaluation of PK endpoints or because of non-evaluability.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| R - Low Dose of BI 655130 Periumbilical | Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 1243.29 day * microgram / milliliter |
| T1 - Low Dose of BI 655130 Periumbilical (Left and Right) | Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 1163.47 day * microgram / milliliter |
| T2 - Low Dose of BI 655130 Thigh | Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 1737.28 day * microgram / milliliter |
Comparison: Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.90% CI: [78.11, 112.11]
Comparison: Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.90% CI: [116.64, 167.4]
Secondary
Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞), Dose-Normalized
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), dose-normalized. Participants assigned to the Test Treatment Group T3 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R. mL = milliliter, mg = milligram.
Time frame: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.
Population: Pharmacokinetic (PK) parameter set: all participants in the Treated set (all participants who received at least one dose of study drug) who provided at least one primary or secondary PK parameter that was not excluded because of important protocol deviations relevant to the statistical evaluation of PK endpoints or because of non-evaluability.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| R - Low Dose of BI 655130 Periumbilical | Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞), Dose-Normalized | 4.14 day * microgram * (1 / mL) * (1 / mg) |
| T1 - Low Dose of BI 655130 Periumbilical (Left and Right) | Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞), Dose-Normalized | 5.03 day * microgram * (1 / mL) * (1 / mg) |
Comparison: Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.90% CI: [101.28, 145.37]