Neoplasms
Conditions
Brief summary
This study is open to adults with different types of advanced cancer (solid tumours). This study is open to people in whom previous treatments were not successful. The purpose of this study is to find out the highest dose of BI 905677 the participants can tolerate. BI 905677 is a type of an antibody that is being developed to treat cancer. One dose of BI 905677 is given to the participants every 2 or 3 weeks as infusion into a vein. In this study, BI 905677 is given to humans for the first time. The participants visit the study site at least once a week so that the doctors can check their general health. The participants are in the study for as long as they benefit from and can tolerate treatment.
Interventions
DRUGBI 905677
Solution for infusion
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy. Patient must have measurable or evaluable lesions (according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1). * Patient who has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted treatment options known to prolong survival for their disease. * Patient willing to undergo mandatory skin biopsy at the timepoints specified in the protocol. * Eastern Cooperative Oncology Group score of 0 or 1. * Adequate organ function defined as all of the following: * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; haemoglobin ≥ 9.0 g/dL; platelets ≥ 100 x 109/L without the use of hematopoietic growth factors within 4 weeks of start of study medication. * Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), except for patients with Gilbert's syndrome: total bilirubin ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN. * Creatinine ≤ 1.5 x ULN. If creatinine is \> 1.5 x ULN, patient is eligible if concurrent creatinine clearance ≥ 50 ml/min (measured or calculated by CKDEPI formula or Japanese version of CKD-EPI formula for Japanese patients). * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN * Alkaline Phosphatase \< 5 x ULN * Recovered from any previous therapy-related toxicity to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at start of treatment (except for alopecia and stable sensory neuropathy which must be ≤ CTCAE Grade 2). * At least 18 years of age at the time of consent or over the legal age of consent in countries where that is greater than 18 years. * Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. * Life expectancy ≥ 3 months at the start of treatment in the opinion of the investigator. * Male or female patients. Women of childbearing potential (WOCBP) must only be included after a confirmed menstrual period within the past 4 weeks and a negative pregnancy test at screening. WOCBP with irregular menstruation may be included after two negative pregnancy tests during screening between 2 and 4 weeks apart. WOCBP and men who are able to father a child must be ready and able to use highly effective methods of birth control, per ICH M3 (R2), that result in a low failure rate of less than 1% per year when used consistently and correctly. These methods must be used during the study and for at least 6 months after the last dose of BI 905677. A list of contraception methods meeting these criteria is provided in the patient information.
Exclusion criteria
* Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to first trial treatment or planned within 6 months after screening. * Previous or concomitant malignancies other than the one treated in this trial within the last 2 years, except; * effectively treated non-melanoma skin cancers * effectively treated carcinoma in situ of the cervix * effectively treated ductal carcinoma in situ * other effectively treated malignancy that is considered cured by local treatment * Osteoporosis ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 * Chronic corticosteroid use * Osteoporotic compression fracture within 12 months prior to informed consent which is clinically significant in the opinion of the investigator. * Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial. * Previous treatment in this trial. * Treatment with a systemic anti-cancer therapy or investigational drug within 28 days or 5 half-lives (whichever is shorter) of the first treatment with the study medication. * Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the safety and efficacy of the test drug. * Women who are pregnant, nursing, or who plan to become pregnant or nurse during the trial or within 6 months after the last dose of study treatment. * Active alcohol or drug abuse in the opinion of the investigator. * Patient unwilling or unable to comply with the protocol. * Presence or history of uncontrolled or symptomatic brain or subdural metastases, unless considered stable by the investigator and local therapy was completed. Inclusion of patients with newly identified brain metastasis/es at screening will be allowed if patients are asymptomatic. * Known history of human immunodeficiency virus (HIV) infection or an active hepatitis B or C infection which in the opinion of the investigator may interfere with participation in the trial. * History of severe hypersensitivity reactions to monoclonal antibodies. * History of allergy to kanamycin or similar class drugs (including streptomycin, gentamicin, amikacin, tobramycin and neomycin).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | In the first treatment cycle, up to 3 weeks | The number of participants with Dose Limiting Toxicities (DLTs) is reported. Any of the following adverse events (AEs) will be classified as DLTs following review by the Safety Monitoring Committee and the Medical Monitor, unless unequivocally due to underlying malignancy or an extraneous cause, including any AE which prevents a patient starting Cycle 2 within 14 days of completion of Cycle 1; Bone mineral density change of \>5% from baseline, confirmed at least 2 months after initial observation; β-CTX increase of more than two-fold from baseline; Grade 3 osteoporosis, and so on. |
| Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period | From first dose until last dose + 42 days (6 weeks) of residual effect period, up to 36 weeks. | The Number of patients experiencing adverse events (AEs) during the entire treatment period is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Measured Concentration of BI 905677 in Serum After First Infusion (Cmax) | 5 minutes (min) before and at 1, 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1. | The Maximum measured concentration of BI 905677 in serum after first infusion is reported. |
| Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (AUC0-tz) | 5 minutes (min) before and at 1 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1. | The Area under the serum concentration-time curve over the time interval from 0 to the last measured time point is reported. |
Countries
Japan, Netherlands, Spain, United States
Participant flow
Recruitment details
This non-randomised, open-label, single arm, dose escalation trial was planned to determine the maximum tolerated dose (MTD) of BI 905677 given as an intravenous infusion and to determine the recommended dose and dosing schedule for further trials in the development of BI 905677. Two treatment schedules (A and B) were planned. But only Schedule A was conducted.
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 |
|---|---|
| BI 905677 0.05 mg/kg 0.05 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. | 3 |
| BI 905677 0.1 mg/kg 0.1 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. | 3 |
| BI 905677 0.2 mg/kg 0.2 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. | 3 |
| BI 905677 0.4 mg/kg 0.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. | 3 |
| BI 905677 0.8 mg/kg 0.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. | 3 |
| BI 905677 1.6 mg/kg 1.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. | 6 |
| BI 905677 2.4 mg/kg 2.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. | 6 |
| BI 905677 2.8 mg/kg 2.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. | 7 |
| BI 905677 3.6 mg/kg 3.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 was administered intravenously on Day 1 of each 3-week treatment cycle. Patients could stay on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment were met. | 3 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Missing visit | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | BI 905677 0.05 mg/kg | BI 905677 0.1 mg/kg | BI 905677 0.2 mg/kg | BI 905677 0.4 mg/kg | BI 905677 0.8 mg/kg | BI 905677 1.6 mg/kg | BI 905677 2.4 mg/kg | BI 905677 2.8 mg/kg | BI 905677 3.6 mg/kg | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 52.3 Years STANDARD_DEVIATION 17.4 | 57.7 Years STANDARD_DEVIATION 8 | 54.7 Years STANDARD_DEVIATION 10 | 58.3 Years STANDARD_DEVIATION 10.7 | 50.7 Years STANDARD_DEVIATION 7.6 | 58.3 Years STANDARD_DEVIATION 11.3 | 55.0 Years STANDARD_DEVIATION 10.8 | 52.3 Years STANDARD_DEVIATION 14.9 | 64.0 Years STANDARD_DEVIATION 2.6 | 55.6 Years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 5 Participants | 6 Participants | 7 Participants | 2 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 1 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 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 | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 5 Participants | 2 Participants | 24 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants | 1 Participants | 4 Participants | 1 Participants | 13 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 1 Participants | 2 Participants | 5 Participants | 3 Participants | 2 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 1 / 3 | 0 / 3 | 1 / 3 | 1 / 3 | 0 / 6 | 2 / 6 | 1 / 7 | 1 / 3 |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 2 / 3 | 3 / 3 | 3 / 3 | 6 / 6 | 6 / 6 | 7 / 7 | 3 / 3 |
| serious Total, serious adverse events | 1 / 3 | 2 / 3 | 1 / 3 | 2 / 3 | 1 / 3 | 2 / 6 | 4 / 6 | 7 / 7 | 3 / 3 |
Outcome results
Primary
Number of Participants With Dose Limiting Toxicities (DLTs)
The number of participants with Dose Limiting Toxicities (DLTs) is reported. Any of the following adverse events (AEs) will be classified as DLTs following review by the Safety Monitoring Committee and the Medical Monitor, unless unequivocally due to underlying malignancy or an extraneous cause, including any AE which prevents a patient starting Cycle 2 within 14 days of completion of Cycle 1; Bone mineral density change of \>5% from baseline, confirmed at least 2 months after initial observation; β-CTX increase of more than two-fold from baseline; Grade 3 osteoporosis, and so on.
Time frame: In the first treatment cycle, up to 3 weeks
Population: Maximum Tolerated Dose (MTD) Evaluation Set (MTDS): includes all patients in the treated set who were not replaced for the MTD determination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BI 905677 0.05 mg/kg | Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| BI 905677 0.1 mg/kg | Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| BI 905677 0.2 mg/kg | Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| BI 905677 0.4 mg/kg | Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| BI 905677 0.8 mg/kg | Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| BI 905677 1.6 mg/kg | Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| BI 905677 2.4 mg/kg | Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| BI 905677 2.8 mg/kg | Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| BI 905677 3.6 mg/kg | Number of Participants With Dose Limiting Toxicities (DLTs) | 3 Participants |
Comparison: Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.
Comparison: Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.
Comparison: Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.
Comparison: Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.
Comparison: Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.
Comparison: Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.
Comparison: Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.
Comparison: Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.
Comparison: Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.
Primary
Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period
The Number of patients experiencing adverse events (AEs) during the entire treatment period is reported.
Time frame: From first dose until last dose + 42 days (6 weeks) of residual effect period, up to 36 weeks.
Population: Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BI 905677 0.05 mg/kg | Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period | 3 Participants |
| BI 905677 0.1 mg/kg | Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period | 3 Participants |
| BI 905677 0.2 mg/kg | Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period | 2 Participants |
| BI 905677 0.4 mg/kg | Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period | 3 Participants |
| BI 905677 0.8 mg/kg | Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period | 3 Participants |
| BI 905677 1.6 mg/kg | Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period | 6 Participants |
| BI 905677 2.4 mg/kg | Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period | 6 Participants |
| BI 905677 2.8 mg/kg | Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period | 7 Participants |
| BI 905677 3.6 mg/kg | Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period | 3 Participants |
Secondary
Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (AUC0-tz)
The Area under the serum concentration-time curve over the time interval from 0 to the last measured time point is reported.
Time frame: 5 minutes (min) before and at 1 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1.
Population: Pharmacokinetics (PK) Analysis Set (PKS): The PK set included all patients in the treated set who provided at least one observation for at least one PK endpoint without important protocol violations relevant to the evaluation of PK. Only participants with non-missing outcomes were included in the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BI 905677 0.05 mg/kg | Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (AUC0-tz) | 8260 nanogram * hour / milliliter | Geometric Coefficient of Variation 64.5 |
| BI 905677 0.1 mg/kg | Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (AUC0-tz) | 26000 nanogram * hour / milliliter | Geometric Coefficient of Variation 11 |
| BI 905677 0.2 mg/kg | Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (AUC0-tz) | 49700 nanogram * hour / milliliter | Geometric Coefficient of Variation 16 |
| BI 905677 0.4 mg/kg | Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (AUC0-tz) | 144000 nanogram * hour / milliliter | Geometric Coefficient of Variation 66.6 |
| BI 905677 0.8 mg/kg | Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (AUC0-tz) | 258000 nanogram * hour / milliliter | Geometric Coefficient of Variation 43.7 |
| BI 905677 1.6 mg/kg | Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (AUC0-tz) | 694000 nanogram * hour / milliliter | Geometric Coefficient of Variation 22.3 |
| BI 905677 2.4 mg/kg | Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (AUC0-tz) | 1130000 nanogram * hour / milliliter | Geometric Coefficient of Variation 10.6 |
| BI 905677 2.8 mg/kg | Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (AUC0-tz) | 1170000 nanogram * hour / milliliter | Geometric Coefficient of Variation 30.4 |
| BI 905677 3.6 mg/kg | Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (AUC0-tz) | 1950000 nanogram * hour / milliliter | Geometric Coefficient of Variation 32.5 |
Secondary
Maximum Measured Concentration of BI 905677 in Serum After First Infusion (Cmax)
The Maximum measured concentration of BI 905677 in serum after first infusion is reported.
Time frame: 5 minutes (min) before and at 1, 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1.
Population: Pharmacokinetics (PK) Analysis Set (PKS): The PK set included all patients in the treated set who provided at least one observation for at least one PK endpoint without important protocol violations relevant to the evaluation of PK. Only participants with non-missing outcomes were included in the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BI 905677 0.05 mg/kg | Maximum Measured Concentration of BI 905677 in Serum After First Infusion (Cmax) | 512 nanogram / milliliter | Geometric Coefficient of Variation 20.7 |
| BI 905677 0.1 mg/kg | Maximum Measured Concentration of BI 905677 in Serum After First Infusion (Cmax) | 1100 nanogram / milliliter | Geometric Coefficient of Variation 22 |
| BI 905677 0.2 mg/kg | Maximum Measured Concentration of BI 905677 in Serum After First Infusion (Cmax) | 1720 nanogram / milliliter | Geometric Coefficient of Variation 6.59 |
| BI 905677 0.4 mg/kg | Maximum Measured Concentration of BI 905677 in Serum After First Infusion (Cmax) | 4890 nanogram / milliliter | Geometric Coefficient of Variation 23.1 |
| BI 905677 0.8 mg/kg | Maximum Measured Concentration of BI 905677 in Serum After First Infusion (Cmax) | 6540 nanogram / milliliter | Geometric Coefficient of Variation 30.9 |
| BI 905677 1.6 mg/kg | Maximum Measured Concentration of BI 905677 in Serum After First Infusion (Cmax) | 13700 nanogram / milliliter | Geometric Coefficient of Variation 25.8 |
| BI 905677 2.4 mg/kg | Maximum Measured Concentration of BI 905677 in Serum After First Infusion (Cmax) | 23100 nanogram / milliliter | Geometric Coefficient of Variation 17.6 |
| BI 905677 2.8 mg/kg | Maximum Measured Concentration of BI 905677 in Serum After First Infusion (Cmax) | 26800 nanogram / milliliter | Geometric Coefficient of Variation 18.5 |
| BI 905677 3.6 mg/kg | Maximum Measured Concentration of BI 905677 in Serum After First Infusion (Cmax) | 47500 nanogram / milliliter | Geometric Coefficient of Variation 17.1 |