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Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 409306 tablets in healthy Chinese and Japanese male volunteers of a known genotype as specified in the study protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment |
|
| BI-409306 25 milligram (mg) SD | Experimental | Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 |
|
| BI-409306 50 mg SD | Experimental | Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 |
|
| BI-409306 100 mg SD | Experimental | Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 |
|
| BI-409306 100 mg MDBI-409306 100 mg SD & MD | Experimental | Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first does of multipled dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage (%) of Subjects With Drug-related Adverse Events (AEs) | Percentage (%) of subjects with drug-related adverse events (AEs). | From first drug administration until 11 days after last dose of study medication, up to 18 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measured Concentration of a Single Dose of BI 409306 in Plasma (Cmax) | Maximum measured concentration of a single dose of BI 409306 in plasma (Cmax). | PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration. |
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Inclusion criteria:
Exclusion criteria:
1. Any deviation from healthy condition
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1289.4.8201 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
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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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This was randomised, placebo controlled and double-blind within dose groups, single dose (3 dose groups), multiple dose (1 dose group, 8-day treatment), single centre trial with healthy Chinese and Japanese male volunteers
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment |
| FG001 | BI-409306 25 Milligram (mg) SD | Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 |
| FG002 | BI-409306 50 mg SD | Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 |
| FG003 | BI-409306 100 mg SD | Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 |
| FG004 | BI-409306 100 mg SD & MD | Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first dose of multiple dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Single Dose Segment (Day 1) |
|
| ||||||||||||||||||
| Washout (48 Hours) |
| |||||||||||||||||||
| Multiple Dose Segment (Days3-9) |
|
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment |
| BG001 | BI-409306 25 Milligram (mg) SD |
| 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 Subjects With Drug-related Adverse Events (AEs) | Percentage (%) of subjects with drug-related adverse events (AEs). | Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication. | Posted | Number | Percentage of Participants | From first drug administration until 11 days after last dose of study medication, up to 18 days. |
|
From first drug administration until 11 days after last dose of study medication, up to 18 days.
Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.
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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 | Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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|
| BI-409306 25 milligram (mg) SD | Drug | Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 |
|
| BI-409306 50 mg SD | Drug | Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 |
|
| BI-409306 100 mg SD | Drug | Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 |
|
| BI-409306 100 mg MD | Drug | Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9 |
|
| Area Under the Concentration-time Curve of a Single Dose of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) |
Area under the concentration-time curve of a single dose of BI 409306 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity). |
| PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration. |
| Area Under the Concentration-time Curve of a Single Dose of BI 409306 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of a single dose of BI 409306 in plasma over the time interval 0 to the last quantifiable data point (AUC0-tz). | PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration. |
| Maximum Measured Concentration of the Metabolite CD 13896 in Plasma (Cmax) | Maximum measured concentration of the metabolite CD 13896 in plasma (Cmax) after single administration of BI 409306. | PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration. |
| Maximum Measured Concentration of the Metabolite CD 14084 in Plasma (Cmax) | Maximum measured concentration of the metabolite CD 14084 in plasma (Cmax) after single administration of BI 409306. | PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration. |
| Area Under the Concentration-time Curve of the Metabolite CD 13896 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) | Area under the concentration-time curve of the metabolite CD 13896 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity) after single administration of BI 409306. | PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration. |
| Area Under the Concentration-time Curve of the Metabolite CD 14084 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) | Area under the concentration-time curve of the metabolite CD 14084 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity) after single administration of BI 409306. | PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration. |
| Area Under the Concentration-time Curve of the Metabolite CD 13896 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz). | Area under the concentration-time curve of the metabolite CD 13896 in plasma over the time interval 0 to the last quantifiable data point (AUC0-tz) after single administration of BI 409306. | PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration. |
| Area Under the Concentration-time Curve of the Metabolite CD 14084 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz). | Area under the concentration-time curve of the metabolite CD 14084 in plasma over the time interval 0 to the last quantifiable data point (AUC0-tz) after single administration of BI 409306. | PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration. |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 |
| BG002 | BI-409306 50 mg SD | Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 |
| BG003 | BI-409306 100 mg SD | Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 |
| BG004 | BI-409306 100 mg SD & MD | Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first dose of multiple dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes. |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Poor metaboliser (PM) / extensive metaboliser (EM) | Number of subjects per category: Poor metaboliser (PM) / extensive metaboliser (EM). | Count of Participants | Participants |
|
| Ethnicity | Count of Participants | Participants |
|
Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
| OG002 | BI-409306 50 mg SD | Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 |
| OG003 | BI-409306 100 mg SD | Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 |
| OG004 | BI-409306 100 mg MD-PM | Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9 in multiple dose (MD) segment |
| OG005 | BI-409306 100 mg SD-PM | Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 in multiple dose (MD) segment |
|
|
| Secondary | Maximum Measured Concentration of a Single Dose of BI 409306 in Plasma (Cmax) | Maximum measured concentration of a single dose of BI 409306 in plasma (Cmax). | The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least one evaluable observation for at least one pharmacokinetic (PK) endpoint without Important protocol violation (IPV) that could potentially influence the results of PK measurements for determination of primary PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomol (nmol) / Litre (L) | PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration. |
|
|
|
|
| Secondary | Area Under the Concentration-time Curve of a Single Dose of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) | Area under the concentration-time curve of a single dose of BI 409306 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity). | The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least one evaluable observation for at least one pharmacokinetic (PK) endpoint without Important protocol violation (IPV) that could potentially influence the results of PK measurements for determination of primary PK endpoints. Only subjects with non missing values were included in the endpoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomol (nmol) * hour (h) / Litre (L) | PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration. |
|
|
|
|
| Secondary | Area Under the Concentration-time Curve of a Single Dose of BI 409306 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of a single dose of BI 409306 in plasma over the time interval 0 to the last quantifiable data point (AUC0-tz). | The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least one evaluable observation for at least one pharmacokinetic (PK) endpoint without Important protocol violation (IPV) that could potentially influence the results of PK measurements for determination of primary PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomol (nmol) * hour (h) / Litre (L) | PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration. |
|
|
|
|
| Secondary | Maximum Measured Concentration of the Metabolite CD 13896 in Plasma (Cmax) | Maximum measured concentration of the metabolite CD 13896 in plasma (Cmax) after single administration of BI 409306. | The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least one evaluable observation for at least one pharmacokinetic (PK) endpoint without Important protocol violation (IPV) that could potentially influence the results of PK measurements for determination of primary PK endpoints. As pre-specified in the protocol, metabolite analyses were only planned for the 100 mg extensive metabolizer groups. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomol (nmol) / Litre (L) | PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration. |
|
|
|
| Secondary | Maximum Measured Concentration of the Metabolite CD 14084 in Plasma (Cmax) | Maximum measured concentration of the metabolite CD 14084 in plasma (Cmax) after single administration of BI 409306. | The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least one evaluable observation for at least one pharmacokinetic (PK) endpoint without Important protocol violation (IPV) that could potentially influence the results of PK measurements for determination of primary PK endpoints. As pre-specified in the protocol, metabolite analyses were only planned for the 100 mg extensive metabolizer groups. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomol (nmol) / Litre (L) | PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration. |
|
|
|
| Secondary | Area Under the Concentration-time Curve of the Metabolite CD 13896 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) | Area under the concentration-time curve of the metabolite CD 13896 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity) after single administration of BI 409306. | The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least one evaluable observation for at least one pharmacokinetic (PK) endpoint without Important protocol violation (IPV) that could potentially influence the results of PK measurements for determination of primary PK endpoints. As pre-specified in the protocol, metabolite analyses were only planned for the 100 mg extensive metabolizer groups. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomol (nmol) * hour (h) / Litre (L) | PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration. |
|
|
|
| Secondary | Area Under the Concentration-time Curve of the Metabolite CD 14084 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) | Area under the concentration-time curve of the metabolite CD 14084 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity) after single administration of BI 409306. | The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least one evaluable observation for at least one pharmacokinetic (PK) endpoint without Important protocol violation (IPV) that could potentially influence the results of PK measurements for determination of primary PK endpoints. As pre-specified in the protocol, metabolite analyses were only planned for the 100 mg extensive metabolizer groups. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomol (nmol) * hour (h) / Litre (L) | PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration. |
|
|
|
| Secondary | Area Under the Concentration-time Curve of the Metabolite CD 13896 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz). | Area under the concentration-time curve of the metabolite CD 13896 in plasma over the time interval 0 to the last quantifiable data point (AUC0-tz) after single administration of BI 409306. | The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least one evaluable observation for at least one pharmacokinetic (PK) endpoint without Important protocol violation (IPV) that could potentially influence the results of PK measurements for determination of primary PK endpoints. As pre-specified in the protocol, metabolite analyses were only planned for the 100 mg extensive metabolizer groups. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomol (nmol) * hour (h) / Litre (L) | PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration. |
|
|
|
| Secondary | Area Under the Concentration-time Curve of the Metabolite CD 14084 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz). | Area under the concentration-time curve of the metabolite CD 14084 in plasma over the time interval 0 to the last quantifiable data point (AUC0-tz) after single administration of BI 409306. | The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least one evaluable observation for at least one pharmacokinetic (PK) endpoint without Important protocol violation (IPV) that could potentially influence the results of PK measurements for determination of primary PK endpoints. As pre-specified in the protocol, metabolite analyses were only planned for the 100 mg extensive metabolizer groups. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomol (nmol) * hour (h) / Litre (L) | PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration. |
|
|
|
| 0 |
| 15 |
| 2 |
| 15 |
| EG001 | BI-409306 25 Milligram (mg) SD | Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 | 0 | 11 | 1 | 11 |
| EG002 | BI-409306 50 mg SD | Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 | 0 | 11 | 5 | 11 |
| EG003 | BI-409306 100 mg SD | Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 | 0 | 19 | 11 | 19 |
| EG004 | BI-409306 100 mg SD-PM | Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 in multiple dose (MD) segment | 0 | 6 | 5 | 6 |
| EG005 | BI-409306 100 mg MD-PM | Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9 in multiple dose (MD) segment | 0 | 6 | 5 | 6 |
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chromatopsia | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 16.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Dose proportionality was assessed in Japanese subjects. For the power model perfect dose proportionality would correspond to a slope of 1. |
| Slope |
| 1.3652 |
| 2-Sided |
| 95 |
| 1.0421 |
| 1.6883 |
The standard error of slope estimate = 0.1516. |
| Superiority or Other (legacy) |
Dose proportionality was assessed in Japanese subjects. For the power model perfect dose proportionality would correspond to a slope of 1. |
| Slope |
| 1.0299 |
| 2-Sided |
| 95 |
| 0.7131 |
| 1.3466 |
The standard error of slope estimate = 0.1486. |
| Superiority or Other (legacy) |
Dose proportionality was assessed in Japanese subjects. For the power model perfect dose proportionality would correspond to a slope of 1. |
| Slope |
| 1.0301 |
| 2-Sided |
| 95 |
| 0.7133 |
| 1.3469 |
The standard error of slope estimate = 0.1486. |
| Superiority or Other (legacy) |