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Safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects following oral administration of single rising doses (SRD) followed by multiple rising doses (MRD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRD part (low dose) | Experimental | Chinese, Japanese both |
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| SRD part (medium dose) | Experimental | Chinese, Japanese both |
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| SRD part (high dose) | Experimental | Chinese, Japanese both |
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| MD part (high dose) | Experimental | Chinese, Japanese both |
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| Placebo (SRD part) | Experimental | placebo |
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| Placebo (MD part) | Placebo Comparator | placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1026706 | Drug | oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Drug-related Adverse Events (AEs) | The percentage of subjects with drug-related AEs indicate the safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects following oral administration of single rising doses of 25 mg, 50 mg, and 100 mg, followed by multiple doses of 100 mg bid. | From first drug administration to 4 days after last drug intake, up to 19 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | This outcome measure presents maximum measured concentration of the analyte [BI 1026706] in plasma. TS-SRD part: This subject set included all subjects who were dispensed BI 1026706 and were documented to have taken at least 1 dose of investigational treatment in the SRD part. All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Souseikai Hakata Clinic | Fukuoka, Fukuoka | 812-0025 | Japan |
Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue therapies was allowed for all subjects as required.
This was a randomised, double-blind, placebo-controlled, single-centre trial investigating single rising dose (SRD) groups (25 milligram (mg), 50 mg and 100 mg) and a multiple dose (MD) (100 mg) in healthy Chinese and Japanese male subjects. This trial had an SRD plus MD nested design. All subjects from SRD 100 mg also participated in the MD part.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | The subjects were administered film-coated tablets matching placebo orally with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h). |
| FG001 | BI 1026706 25 mg | The subjects were administered 25 mg film-coated tablet single dose orally with 240 mL water after an overnight fast of at least 10h. |
| FG002 | BI 1026706 50 mg | The subjects were administered 50 mg [25 mg*2] film-coated tablets single dose orally with 240 mL water after an overnight fast of at least 10h. |
| FG003 | BI 1026706 100 mg | The subjects were administered 100 mg film-coated tablet [SRD] as single dose followed with 100 mg film-coated tablets [MD] twice daily for 11 days with a final single dose in the morning of Day 12 orally with 240 mL water after an overnight fast of at least 10h. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Treated Set (TS) : This subject set included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | The subjects were administered film-coated tablets matching placebo orally with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h). |
| BG001 | BI 1026706 25 mg |
| Units | Counts |
|---|---|
| Participants |
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| 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 Subjects With Drug-related Adverse Events (AEs) | The percentage of subjects with drug-related AEs indicate the safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects following oral administration of single rising doses of 25 mg, 50 mg, and 100 mg, followed by multiple doses of 100 mg bid. | Treated set (TS) : This subject set included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment. | Posted | Number | Percentage of participants | From first drug administration to 4 days after last drug intake, up to 19 days. |
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From first drug administration to 4 days after last drug intake, up to 19 days.
This trial had an SRD plus MD nested design. All subjects from SRD 100 mg also participated in the MD part.
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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 | The subjects were administered film-coated tablets matching placebo orally with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Faeces soft | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Placebo | Drug | placebo |
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| -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration. |
| Tmax | This outcome measure presents time from dosing to maximum measured concentration of the analyte [BI 1026706] in plasma. All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint. | -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration. |
| AUC0-12 | This outcome measure presents area under the concentration-time curve of the analyte [BI 1026706] in plasma over the time interval from 0 extrapolated to 12 hours (AUC0-12). All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint. | -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration. |
| AUC0-infinity | This outcome measure presents area under the concentration-time curve of the analyte [BI 1026706] in plasma over the time interval from 0 extrapolated to infinity. All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint. | -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration. |
| t1/2 | This outcome measure presents terminal half-life of the analyte [BI 1026706] in plasma. All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint. | -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration. |
| Cmax,ss | This outcome measure presents maximum measured concentration of the analyte [BI 1026706] in plasma at steady state over a uniform dosing interval tau. TS-MD part: This subject set included all subjects from the 100 mg group in the SRD part who were dispensed BI 1026706 and were documented to have taken at least 1 dose of investigational treatment in the MD part. All subjects in the TS-MD part who provide at least 1 PK parameter in the MD part that was not excluded were to be considered for this endpoint. | 23:55, 47:55, 71:55, 95:55, 119:55, 167:55, 239:55, 263:55, 264:15, 264:30, 264:45, 265:00, 265:30, 266:00, 266:30, 267:00, 268:00, 270:00, 272:00, 274:00, 276:00, 288:00, 298:00, 312:00 and 336:00 (hours:minutes) after drug administration. |
| Tmax,ss | This outcome measure presents time from last dosing to maximum concentration of the analyte [BI 1026706] in plasma at steady state (tmax,ss) . All subjects in the TS-MD part who provide at least 1 PK parameter in the MD part that was not excluded were to be considered for this endpoint. | 23:55, 47:55, 71:55, 95:55, 119:55, 167:55, 239:55, 263:55, 264:15, 264:30, 264:45, 265:00, 265:30, 266:00, 266:30, 267:00, 268:00, 270:00, 272:00, 274:00, 276:00, 288:00, 298:00, 312:00 and 336:00 (hours:minutes) after drug administration. |
| AUC Tau,ss | This outcome measure presents area under the concentration-time curve of the analyte [BI 1026706] in plasma at steady state over a uniform dosing interval tau (AUC tau,ss). All subjects in the TS-MD part who provide at least 1 PK parameter in the MD part that was not excluded were to be considered for this endpoint. | 23:55, 47:55, 71:55, 95:55, 119:55, 167:55, 239:55, 263:55, 264:15, 264:30, 264:45, 265:00, 265:30, 266:00, 266:30, 267:00, 268:00, 270:00, 272:00, 274:00, 276:00, 288:00, 298:00, 312:00 and 336:00 (hours:minutes) after drug administration. |
The subjects were administered 25 mg film-coated tablet single dose orally with 240 mL water after an overnight fast of at least 10h.
| BG002 | BI 1026706 50 mg | The subjects were administered 50 mg [25 mg*2] film-coated tablets single dose orally with 240 mL water after an overnight fast of at least 10h. |
| BG003 | BI 1026706 100 mg | The subjects were administered 100 mg film-coated tablet [SRD] as single dose followed with 100 mg film-coated tablets [MD] twice daily for 11 days with a final single dose in the morning of Day 12 orally with 240 mL water after an overnight fast of at least 10h. |
| BG004 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 |
| BI 1026706 25 mg |
The subjects were administered 25 mg film-coated tablet single dose orally with 240 mL water after an overnight fast of at least 10h. |
| OG002 | BI 1026706 50 mg | The subjects were administered 50 mg [25 mg*2] film-coated tablets single dose orally with 240 mL water after an overnight fast of at least 10h. |
| OG003 | BI 1026706 100 mg | The subjects were administered 100 mg film-coated tablet [SRD] as single dose followed with 100 mg film-coated tablets [MD] twice daily for 11 days with a final single dose in the morning of Day 12 orally with 240 mL water after an overnight fast of at least 10h. |
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| Secondary | Cmax | This outcome measure presents maximum measured concentration of the analyte [BI 1026706] in plasma. TS-SRD part: This subject set included all subjects who were dispensed BI 1026706 and were documented to have taken at least 1 dose of investigational treatment in the SRD part. All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint. | PharmacoKinetic Set (PKS)-SRD part: This set included all evaluable subjects of the TS-SRD part who were administered BI 1026706, and provided at least 1 observation for at least 1 pharmacokinetic (PK) secondary endpoint without important protocol violations relevant for the evaluation of PK secondary endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole (nmol)/Liter (L) | -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration. |
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| Secondary | Tmax | This outcome measure presents time from dosing to maximum measured concentration of the analyte [BI 1026706] in plasma. All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint. | PKS-SRD part. | Posted | Median | Full Range | h | -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration. |
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| Secondary | AUC0-12 | This outcome measure presents area under the concentration-time curve of the analyte [BI 1026706] in plasma over the time interval from 0 extrapolated to 12 hours (AUC0-12). All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint. | PKS-SRD part. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration. |
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| Secondary | AUC0-infinity | This outcome measure presents area under the concentration-time curve of the analyte [BI 1026706] in plasma over the time interval from 0 extrapolated to infinity. All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint. | PKS-SRD part. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration. |
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| Secondary | t1/2 | This outcome measure presents terminal half-life of the analyte [BI 1026706] in plasma. All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint. | PKS-SRD part. | Posted | Geometric Mean | Geometric Coefficient of Variation | h | -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration. |
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| Secondary | Cmax,ss | This outcome measure presents maximum measured concentration of the analyte [BI 1026706] in plasma at steady state over a uniform dosing interval tau. TS-MD part: This subject set included all subjects from the 100 mg group in the SRD part who were dispensed BI 1026706 and were documented to have taken at least 1 dose of investigational treatment in the MD part. All subjects in the TS-MD part who provide at least 1 PK parameter in the MD part that was not excluded were to be considered for this endpoint. | PKS-MD part: This set included all evaluable subjects of the TS-MD part who were administered BI 1026706, and provided at least 1 observation for at least 1 PK secondary endpoint without important protocol violations relevant for the evaluation of PK secondary endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 23:55, 47:55, 71:55, 95:55, 119:55, 167:55, 239:55, 263:55, 264:15, 264:30, 264:45, 265:00, 265:30, 266:00, 266:30, 267:00, 268:00, 270:00, 272:00, 274:00, 276:00, 288:00, 298:00, 312:00 and 336:00 (hours:minutes) after drug administration. |
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| Secondary | Tmax,ss | This outcome measure presents time from last dosing to maximum concentration of the analyte [BI 1026706] in plasma at steady state (tmax,ss) . All subjects in the TS-MD part who provide at least 1 PK parameter in the MD part that was not excluded were to be considered for this endpoint. | PKS-MD part. | Posted | Median | Full Range | h | 23:55, 47:55, 71:55, 95:55, 119:55, 167:55, 239:55, 263:55, 264:15, 264:30, 264:45, 265:00, 265:30, 266:00, 266:30, 267:00, 268:00, 270:00, 272:00, 274:00, 276:00, 288:00, 298:00, 312:00 and 336:00 (hours:minutes) after drug administration. |
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| Secondary | AUC Tau,ss | This outcome measure presents area under the concentration-time curve of the analyte [BI 1026706] in plasma at steady state over a uniform dosing interval tau (AUC tau,ss). All subjects in the TS-MD part who provide at least 1 PK parameter in the MD part that was not excluded were to be considered for this endpoint. | PKS-MD part. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 23:55, 47:55, 71:55, 95:55, 119:55, 167:55, 239:55, 263:55, 264:15, 264:30, 264:45, 265:00, 265:30, 266:00, 266:30, 267:00, 268:00, 270:00, 272:00, 274:00, 276:00, 288:00, 298:00, 312:00 and 336:00 (hours:minutes) after drug administration. |
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| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | BI 1026706 25 mg | The subjects were administered 25 mg film-coated tablet single dose orally with 240 mL water after an overnight fast of at least 10h. | 0 | 18 | 0 | 18 |
| EG002 | BI 1026706 50 mg | The subjects were administered 50 mg [25 mg*2] film-coated tablets single dose orally with 240 mL water after an overnight fast of at least 10h. | 0 | 18 | 0 | 18 |
| EG003 | BI 1026706 100 mg | The subjects were administered 100 mg film-coated tablet [SRD] as single dose followed with 100 mg film-coated tablets [MD] twice daily for 11 days with a final single dose in the morning of Day 12 orally with 240 mL water after an overnight fast of at least 10h. | 0 | 18 | 2 | 18 |
| Blood creatine phosphokinase increased | Investigations | MedDRA 19.1 | 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.
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