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Part I: The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy Japanese male subjects following oral administration of multiple rising doses.
Part II: The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy Chinese male subjects following oral administration of single dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Matching BI 706321 (Part I) | Placebo Comparator | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of placebo tablets matching BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of placebo tablets matching BI 706321. |
|
| 2 mg BI 706321 (Part I) | Experimental | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321. |
|
| 5 mg BI 706321 (Part I) | Experimental | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321. |
|
| 8 mg BI 706321 (Part I) | Experimental | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 706321 | Drug | BI 706321, tablet, oral use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Drug-related Adverse Events | The percentage of participants treated with investigational drug who experience such an event. Percentage of participants with treatment-emergent adverse events assessed as drug-related by the investigator are reported. Percentages are calculated using total number of participants per treatment as the denominator. | From 1st drug administration on Day 1 till Day 19 + 16 days Residual Effect Period (REP), up to 35 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Single-Dose Part: Area Under the Concentration-time Curve of the BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUCR0-∞) | The area under the concentration-time curve of the BI 706321 in plasma over the time interval from 0 extrapolated to infinity (AUCR0-∞) after the first dose administration is reported. | Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days after first BI 706321 administration. |
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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) including body temperature, 12-lead electrocardiogram (ECG), and clinical laboratory tests at screening visit
Part I: Japanese ethnicity, according to the following criteria:
-- born in Japan, have lived outside of Japan <10 years
Part II: Chinese ethnicity including Taiwanese, according to the following criteria:
-- have parents and grandparents who are Chinese
Age of 20 to 45 years (inclusive) at screening visit
Body mass index (BMI) of 18.5 to 25.0kg/m2 (inclusive) at screening visit
Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
Willingness to comply with contraception requirements. Subjects who are sexually active must use adequate contraception methods throughout the trial and until three months after the last administration of trial medication. Adequate methods are:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SOUSEIKAI Sumida Hospital | Tokyo, Sumida-ku | 130-0004 | Japan |
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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:
For more details refer to: https://www.mystudywindow.com/msw/datasharing
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48 Japanese male participants who met all inclusion criteria and no exclusion criteria were enrolled in Part I of the trial. All received the trial medication and placebo as planned and completed the trial per protocol. Participants were free to withdraw at any time and were closely monitored. The trial was prematurely discontinued per protocol before Part II began.
This was a randomized, placebo-controlled, double-blind trial conducted in two parts. Part I involved 48 healthy Japanese males who received BI 706321 as single and multiple rising doses. Part II was planned to involve healthy Chinese males receiving a single dose of BI 706321, but the trial was prematurely discontinued before starting Part II, and no participants were enrolled in Part II.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Matching BI 706321 (Part I) | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of placebo tablets matching BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of placebo tablets matching BI 706321. |
| FG001 | 2 mg BI 706321 (Part I) | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321. |
| FG002 | 5 mg BI 706321 (Part I) | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321. |
| FG003 | 8 mg BI 706321 (Part I) | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321. |
| FG004 | 10 mg BI 706321 (Part I) | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Matching BI 706321 (Part I) | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of placebo tablets matching BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of placebo tablets matching BI 706321. |
| 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 | Percentage of Participants With Drug-related Adverse Events | The percentage of participants treated with investigational drug who experience such an event. Percentage of participants with treatment-emergent adverse events assessed as drug-related by the investigator are reported. Percentages are calculated using total number of participants per treatment as the denominator. | Treated set: all participants who were randomized and treated with at least one dose of the study drug. | Posted | Number | Percentage (%) of participants | From 1st drug administration on Day 1 till Day 19 + 16 days Residual Effect Period (REP), up to 35 days. |
|
Adverse Events and All-Cause Mortality: From 1st drug administration on Day 1 till Day 19 + 16 days (REP), up to 35 days
Treated set: all participants who were randomized and treated with at least one dose of the study drug.
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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 | Placebo Matching BI 706321 (Part I) | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of placebo tablets matching BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of placebo tablets matching BI 706321. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
The trial was prematurely discontinued per protocol before Part II began.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | 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 | Dec 10, 2021 | Aug 1, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 19, 2024 | Aug 1, 2025 | SAP_001.pdf |
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|
| 10 mg BI 706321 (Part I) | Experimental | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321. |
|
| Placebo | Drug | Placebo, tablet, oral use |
|
| Single-Dose Part: Maximum Measured Concentration of BI 706321 in Plasma (Cmax) | The maximum measured concentration of BI 706321 in plasma (Cmax) after the first dose administration is reported. | Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days after first BI 706321 administration. |
| Single-Dose Part: Time From Dosing to Maximum Measured Concentration of BI 706321 in Plasma | The time from dosing to maximum measured concentration of BI 706321 in plasma after first drug administration is reported. | Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days after first BI 706321 administration. |
| Area Under the Concentration-time Curve of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) | Area under the concentration-time curve of BI 706321 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after single and multiple dose administration is reported. | Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration. |
| Maximum Measured Concentration of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) | Maximum measured concentration of BI 706321 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after single and multiple dose administration is reported | Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration. |
| Minimum Concentration of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss) | Minimum concentration of BI 706321 in plasma at steady state over a uniform dosing interval τ (Cmin,ss) after single and multiple dose administration is reported. | Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration. |
| Accumulation Ratio Based on Cₘₐₓ (Rᴀ,ᴄₘₐₓ,ₛₛ) | The accumulation ratio based on Cₘₐₓ (Rᴀ,ᴄₘₐₓ,ₛₛ) shows how much the drug concentration increases at steady state compared to the first dose. It is calculated as a ratio of Cₘₐₓ at steady state (Cₘₐₓ,ₛₛ) and Cₘₐₓ after the first dose (Cₘₐₓ). Rᴀ,ᴄₘₐₓ,ₛₛ = Cₘₐₓₛₛ/Cₘₐₓ. | Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration. |
| Accumulation Ratio Based on AUC₀-ₜ (Rᴀ,ᴀᴜᴄ₀-ₜ,ₛₛ) | The accumulation ratio based on AUC₀-ₜ (Rᴀ,ᴀᴜᴄ₀-ₜ,ₛₛ) shows how much the total drug exposure over a uniform dosing interval τ increases at steady state compared to the first dose. It is calculated as a ration of AUC₀-ₜ at steady state (AUC₀-ₜₛₛ) and AUC₀-ₜ after the first dose (AUC₀-ₜ). Rᴀ,ᴀᴜᴄ₀-ₜ,ₛₛ = AUC₀-ₜₛₛ/AUC₀-ₜ. | Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration. |
| BG001 | 2 mg BI 706321 (Part I) | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321. |
| BG002 | 5 mg BI 706321 (Part I) | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321. |
| BG003 | 8 mg BI 706321 (Part I) | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321. |
| BG004 | 10 mg BI 706321 (Part I) | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321. |
| BG005 | 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 |
|
| OG001 | 2 mg BI 706321 (Part I) | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321. |
| OG002 | 5 mg BI 706321 (Part I) | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321. |
| OG003 | 8 mg BI 706321 (Part I) | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321. |
| OG004 | 10 mg BI 706321 (Part I) | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321. |
|
|
| Secondary | Single-Dose Part: Area Under the Concentration-time Curve of the BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUCR0-∞) | The area under the concentration-time curve of the BI 706321 in plasma over the time interval from 0 extrapolated to infinity (AUCR0-∞) after the first dose administration is reported. | Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (TS) who provide at least one PK endpoint 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 | Hours*(nanomoles/L) | Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days after first BI 706321 administration. |
|
|
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| Secondary | Single-Dose Part: Maximum Measured Concentration of BI 706321 in Plasma (Cmax) | The maximum measured concentration of BI 706321 in plasma (Cmax) after the first dose administration is reported. | Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (TS) who provide at least one PK endpoint 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 | Nanomoles per Liters | Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days after first BI 706321 administration. |
|
|
|
| Secondary | Single-Dose Part: Time From Dosing to Maximum Measured Concentration of BI 706321 in Plasma | The time from dosing to maximum measured concentration of BI 706321 in plasma after first drug administration is reported. | Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (TS) who provide at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Median | Full Range | Hours | Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days after first BI 706321 administration. |
|
|
|
| Secondary | Area Under the Concentration-time Curve of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) | Area under the concentration-time curve of BI 706321 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after single and multiple dose administration is reported. | Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (TS) who provide at least one PK endpoint 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 | Hours*(nanomoles/L) | Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration. |
|
|
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| Secondary | Maximum Measured Concentration of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) | Maximum measured concentration of BI 706321 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after single and multiple dose administration is reported | Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (TS) who provide at least one PK endpoint 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 | Nanomoles per Liters | Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration. |
|
|
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| Secondary | Minimum Concentration of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss) | Minimum concentration of BI 706321 in plasma at steady state over a uniform dosing interval τ (Cmin,ss) after single and multiple dose administration is reported. | Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (TS) who provide at least one PK endpoint 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 | Nanomoles per Liters | Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration. |
|
|
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| Secondary | Accumulation Ratio Based on Cₘₐₓ (Rᴀ,ᴄₘₐₓ,ₛₛ) | The accumulation ratio based on Cₘₐₓ (Rᴀ,ᴄₘₐₓ,ₛₛ) shows how much the drug concentration increases at steady state compared to the first dose. It is calculated as a ratio of Cₘₐₓ at steady state (Cₘₐₓ,ₛₛ) and Cₘₐₓ after the first dose (Cₘₐₓ). Rᴀ,ᴄₘₐₓ,ₛₛ = Cₘₐₓₛₛ/Cₘₐₓ. | Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (TS) who provide at least one PK endpoint 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 | Ratio - no unit | Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration. |
|
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| Secondary | Accumulation Ratio Based on AUC₀-ₜ (Rᴀ,ᴀᴜᴄ₀-ₜ,ₛₛ) | The accumulation ratio based on AUC₀-ₜ (Rᴀ,ᴀᴜᴄ₀-ₜ,ₛₛ) shows how much the total drug exposure over a uniform dosing interval τ increases at steady state compared to the first dose. It is calculated as a ration of AUC₀-ₜ at steady state (AUC₀-ₜₛₛ) and AUC₀-ₜ after the first dose (AUC₀-ₜ). Rᴀ,ᴀᴜᴄ₀-ₜ,ₛₛ = AUC₀-ₜₛₛ/AUC₀-ₜ. | Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (TS) who provide at least one PK endpoint 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 | Ratio - no unit | Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration. |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 5 |
| 12 |
| EG001 | 2 mg BI 706321 (Part I) | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321. | 0 | 9 | 0 | 9 | 2 | 9 |
| EG002 | 5 mg BI 706321 (Part I) | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321. | 0 | 9 | 0 | 9 | 5 | 9 |
| EG003 | 8 mg BI 706321 (Part I) | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321. | 0 | 9 | 0 | 9 | 6 | 9 |
| EG004 | 10 mg BI 706321 (Part I) | This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321. | 0 | 9 | 0 | 9 | 8 | 9 |
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.