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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004937-34 | EudraCT Number | EudraCT |
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To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI 425809 as oral drinking solution; To investigate relative bioavailability of BI 425809 oral drinking solution fasted compared to BI 425809 tablet fasted and tablet fed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRD Part: Placebo | Placebo Comparator | Participants received a single dose of oral solution of placebo matching BI 425809. SRD = Single Rising Dose. |
|
| SRD Part: 0.5 mg BI 425809 | Experimental | Participants received a single dose of oral solution containing 0.5 milligrams (mg) of BI 425809. SRD = Single Rising Dose. |
|
| SRD Part: 1 mg BI 425809 | Experimental | Participants received a single dose of oral solution containing 1 milligram (mg) of BI 425809. SRD = Single Rising Dose. |
|
| SRD Part: 2 mg BI 425809 | Experimental | Participants received a single dose of oral solution containing 2 milligrams (mg) of BI 425809. SRD = Single Rising Dose. |
|
| SRD Part: 5 mg BI 425809 | Experimental | Participants received a single dose of oral solution containing 5 milligrams (mg) of BI 425809. SRD = Single Rising Dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 425809 PfOS | Drug | BI 425809 as a powder for an oral solution (PfOS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Drug-related Adverse Events (AE) | Number of participants with drug-related Adverse Events (AE). Drug-relatedness was assessed by the investigator. | SRD Part: From the time of first drug administration until the end of study, up to 18 days. BA/FE Part: From the time of first drug administration until the end of the intervention period, up to 18 days for each intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| SRD Part: Maximum Concentration of BI 425809 in Plasma (Cmax) | Maximum measured concentration of BI 425809 in plasma (Cmax) in the Single Rising Dose (SRD) part of the trial is reported. | 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration. |
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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 |
|---|---|---|---|---|---|---|
| 1346.1.1 Boehringer Ingelheim Investigational Site | Ingelheim | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29076028 | Derived | Moschetti V, Desch M, Goetz S, Liesenfeld KH, Rosenbrock H, Kammerer KP, Wunderlich G, Wind S. Safety, Tolerability and Pharmacokinetics of Oral BI 425809, a Glycine Transporter 1 Inhibitor, in Healthy Male Volunteers: A Partially Randomised, Single-Blind, Placebo-Controlled, First-in-Human Study. Eur J Drug Metab Pharmacokinet. 2018 Apr;43(2):239-249. doi: 10.1007/s13318-017-0440-z. |
| 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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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All participants were screened for eligibility prior to participation in the trial. Participants attended a specialist site which ensured that they (the participants) strictly met all inclusion and none of the exclusion criteria. Participants were not to be allocated to a treatment group if any of the entry criteria were violated.
Single-rising dose (SRD) part: partially randomized, single-blind, placebo-controlled groups investigated consecutively in ascending dose order. Participants in second cohort per dose randomized in a 3:1 ratio (active treatment/placebo). Bioavailability/Food Effect (BA/FE) part: open-label, randomized, 3-way cross-over design. Treatments: BI 425809 as a tablet without food (R), a tablet with food (T1), and powder in oral solution without food (T2) in 1 of 6 sequences in a 1:1:1:1:1:1 ratio.
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| ID | Title | Description |
|---|---|---|
| FG000 | SRD Part: Placebo | Participants received a single dose of oral solution of placebo matching BI 425809. |
| FG001 | SRD Part: 0.5 mg BI 425809 | Participants received a single dose of oral solution containing 0.5 milligrams (mg) of BI 425809. |
| FG002 | SRD Part: 1 mg BI 425809 | Participants received a single dose of oral solution containing 1 milligram (mg) of BI 425809. |
| FG003 | SRD Part: 2 mg BI 425809 | Participants received a single dose of oral solution containing 2 milligrams (mg) of BI 425809. |
| FG004 | SRD Part: 5 mg BI 425809 | Participants received a single dose of oral solution containing 5 milligrams (mg) of BI 425809. |
| FG005 | SRD Part: 10 mg BI425809 | Participants received a single dose of oral solution containing 10 milligrams (mg) of BI 425809. |
| FG006 | SRD Part: 25 mg BI 425809 | Participants received a single dose of oral solution containing 25 milligrams (mg) of BI 425809. |
| FG007 | SRD Part: 50 mg BI 425809 | Participants received a single dose of oral solution containing 50 milligrams (mg) of BI 425809. |
| FG008 | SRD Part: 100 mg BI 425809 | Participants received a single dose of oral solution containing 100 milligrams (mg) of BI 425809. |
| FG009 | SRD Part: 150 mg BI 425809 | Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809. |
| FG010 | BA/FE Part: 25 mg BI 425809, R/T1/T2 | Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R), 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), and 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2). The 3 treatments were separated by a washout period of at least 14 days. |
| FG011 | BA/FE Part: 25 mg BI 425809, R/T2/T1 | Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R), 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), and 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1). The 3 treatments were separated by a washout period of at least 14 days. |
| FG012 | BA/FE Part: 25 mg BI 425809, T1/T2/R | Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), and 25 mg of BI 425809 as a tablet without food (reference treatment R). The 3 treatments were separated by a washout period of at least 14 days. |
| FG013 | BA/FE Part: 25 mg BI 425809, T1/R/T2 | Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), 25 mg of BI 425809 as a tablet without food (reference treatment R), and 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2). The 3 treatments were separated by a washout period of at least 14 days. |
| FG014 | BA/FE Part: 25 mg BI 425809, T2/T1/R | Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), and 25 mg of BI 425809 as a tablet without food (reference treatment R). The 3 treatments were separated by a washout period of at least 14 days. |
| FG015 | BA/FE Part: 25 mg BI 425809, T2/R/T1 | Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), 25 mg of BI 425809 as a tablet without food (reference treatment R), and 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1). The 3 treatments were separated by a washout period of at least 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated set (TS) - All participants who were treated with at least 1 dose of the study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | SRD Part: Placebo | Participants received a single dose of oral solution of placebo matching BI 425809. |
| BG001 | SRD Part: 0.5 mg BI 425809 | Participants received a single dose of oral solution containing 0.5 milligrams (mg) of BI 425809. |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | SRD Part: Maximum Concentration of BI 425809 in Plasma (Cmax) | Maximum measured concentration of BI 425809 in plasma (Cmax) in the Single Rising Dose (SRD) part of the trial is reported. | Pharmacokinetic set-Dose proportionality (PKS-DP): included all participants of the TS-SRD (Treated Set-Single Rising Dose) on active treatment who provided at least 1 observation for at least 1 of the secondary PK endpoints (Cmax, AUC(0-∞)) without important protocol violations relevant to the statistical evaluation of DP. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomole/Liter | 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration. |
|
SRD Part: From the time of first drug administration until the end of study, up to 18 days. BA/FE Part: From the time of first drug administration until the end of the intervention period, up to 18 days for each intervention.
Treated set (TS) - All participants who were treated with at least 1 dose of the 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 | SRD Part: Placebo | Participants received a single dose of oral solution of placebo matching BI 425809. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| C000634404 | BI 425809 |
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Part 1 of this study was conducted as a sequential assignment, while Part 2 of this study was conducted as a crossover assignment.
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In Part 1 of this study, single-blind conditions regarding the subjects' treatment were maintained within each dose group, but the current dose level was known to subjects and investigators. Part 2 of this study did not have masking and treatments were open-label.
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| SRD Part: 10 mg BI425809 |
| Experimental |
Participants received a single dose of oral solution containing 10 milligrams (mg) of BI 425809. SRD = Single Rising Dose. |
|
| SRD Part: 25 mg BI 425809 | Experimental | Participants received a single dose of oral solution containing 25 milligrams (mg) of BI 425809. SRD = Single Rising Dose. |
|
| SRD Part: 50 mg BI 425809 | Experimental | Participants received a single dose of oral solution containing 50 milligrams (mg) of BI 425809. SRD = Single Rising Dose. |
|
| SRD Part: 100 mg BI 425809 | Experimental | Participants received a single dose of oral solution containing 100 milligrams (mg) of BI 425809. SRD = Single Rising Dose. |
|
| SRD Part: 150 mg BI 425809 | Experimental | Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809. SRD = Single Rising Dose. |
|
| BA/FE Part: 25 mg BI 425809, R/T1/T2 | Experimental | Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R), 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), and 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect. |
|
| BA/FE Part: 25 mg BI 425809, R/T2/T1 | Experimental | Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R), 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), and 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect. |
|
| BA/FE Part: 25 mg BI 425809, T1/T2/R | Experimental | Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), and 25 mg of BI 425809 as a tablet without food (reference treatment R). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect. |
|
| BA/FE Part: 25 mg BI 425809, T1/R/T2 | Experimental | Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), 25 mg of BI 425809 as a tablet without food (reference treatment R), and 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect. |
|
| BA/FE Part: 25 mg BI 425809, T2/T1/R | Experimental | Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), and 25 mg of BI 425809 as a tablet without food (reference treatment R). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect. |
|
| BA/FE Part: 25 mg BI 425809, T2/R/T1 | Experimental | Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), 25 mg of BI 425809 as a tablet without food (reference treatment R), and 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect. |
|
|
| Placebo PfOS | Drug | Placebo as a powder for an oral solution (PfOS) |
|
| BI 425809 tablet | Drug | BI 425809 as a tablet |
|
|
| BA/FE Part: Maximum Concentration of BI 425809 in Plasma (Cmax) | Maximum measured concentration of BI 425809 in plasma (Cmax) in the bioavailability/food effect (BA/FE) part of the trial is reported. | 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration. |
| SRD Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞)) | Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC(0-∞)) in the Single Rising Dose (SRD) part of the trial is reported. | 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration. |
| BA/FE Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞)) | Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC(0-∞)) in the Bioavailability/Food Effect (BA/FE) part of the trial is reported. | 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration. |
| BG002 | SRD Part: 1 mg BI 425809 | Participants received a single dose of oral solution containing 1 milligram (mg) of BI 425809. |
| BG003 | SRD Part: 2 mg BI 425809 | Participants received a single dose of oral solution containing 2 milligrams (mg) of BI 425809. |
| BG004 | SRD Part: 5 mg BI 425809 | Participants received a single dose of oral solution containing 5 milligrams (mg) of BI 425809. |
| BG005 | SRD Part: 10 mg BI425809 | Participants received a single dose of oral solution containing 10 milligrams (mg) of BI 425809. |
| BG006 | SRD Part: 25 mg BI 425809 | Participants received a single dose of oral solution containing 25 milligrams (mg) of BI 425809. |
| BG007 | SRD Part: 50 mg BI 425809 | Participants received a single dose of oral solution containing 50 milligrams (mg) of BI 425809. |
| BG008 | SRD Part: 100 mg BI 425809 | Participants received a single dose of oral solution containing 100 milligrams (mg) of BI 425809. |
| BG009 | SRD Part: 150 mg BI 425809 | Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809. |
| BG010 | BA/FE Part | Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R), 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1) and 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2). The 3 treatments were separated by a washout period of at least 14 days. Participants were randomly allocated to 1 of the 6 treatment sequences: R/T1/T2, R/T2/T1, T1/T2/R, T1/R/T2, T2/T1/R, or T2/R/T1. |
| BG011 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | SRD Part: 1 mg BI 425809 | Participants received a single dose of oral solution containing 1 milligram (mg) of BI 425809. |
| OG002 | SRD Part: 2 mg BI 425809 | Participants received a single dose of oral solution containing 2 milligrams (mg) of BI 425809. |
| OG003 | SRD Part: 5 mg BI 425809 | Participants received a single dose of oral solution containing 5 milligrams (mg) of BI 425809. |
| OG004 | SRD Part: 10 mg BI425809 | Participants received a single dose of oral solution containing 10 milligrams (mg) of BI 425809. |
| OG005 | SRD Part: 25 mg BI 425809 | Participants received a single dose of oral solution containing 25 milligrams (mg) of BI 425809. |
| OG006 | SRD Part: 50 mg BI 425809 | Participants received a single dose of oral solution containing 50 milligrams (mg) of BI 425809. |
| OG007 | SRD Part: 100 mg BI 425809 | Participants received a single dose of oral solution containing 100 milligrams (mg) of BI 425809. |
| OG008 | SRD Part: 150 mg BI 425809 | Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809. |
|
|
|
| Secondary | BA/FE Part: Maximum Concentration of BI 425809 in Plasma (Cmax) | Maximum measured concentration of BI 425809 in plasma (Cmax) in the bioavailability/food effect (BA/FE) part of the trial is reported. | Pharmacokinetic Set-Bioavailability/Food Effect (PKS-BA/FE): included all participants of the TS-BA/FE (Treated Set-Bioavailability/Food Effect) on active treatment who provided at least 1 observation for at least 1 of the secondary PK endpoints (Cmax, AUC(0-∞)) without important protocol violations relevant to the statistical evaluation of BA/FE. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomole/Liter | 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration. |
|
|
|
|
| Secondary | SRD Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞)) | Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC(0-∞)) in the Single Rising Dose (SRD) part of the trial is reported. | Pharmacokinetic Set-Dose Proportionality (PKS-DP): included all participants of the TS-SRD (Treated Set-Single Rising Dose) on active treatment who provided at least 1 observation for at least 1 of the secondary PK endpoints (Cmax, AUC(0-∞)) without important protocol violations relevant to the statistical evaluation of DP. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomole*Hour/Liter | 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration. |
|
|
|
|
| Primary | Number of Participants With Drug-related Adverse Events (AE) | Number of participants with drug-related Adverse Events (AE). Drug-relatedness was assessed by the investigator. | Treated set (TS) - All participants who were treated with at least 1 dose of the study medication. | Posted | Count of Participants | Participants | SRD Part: From the time of first drug administration until the end of study, up to 18 days. BA/FE Part: From the time of first drug administration until the end of the intervention period, up to 18 days for each intervention. |
|
|
|
| Secondary | BA/FE Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞)) | Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC(0-∞)) in the Bioavailability/Food Effect (BA/FE) part of the trial is reported. | Pharmacokinetic Set-Bioavailability/Food Effect (PKS-BA/FE): included all subjects of the TS-BA/FE (Treated Set-Bioavailability/Food Effect) on active treatment who provided at least 1 observation for at least 1 of the secondary PK endpoints (Cmax, AUC(0-∞)) without important protocol violations relevant to the statistical evaluation of BA/FE. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomole*Hour/Liter | 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration. |
|
|
|
|
| 0 |
| 18 |
| 5 |
| 18 |
| EG001 | SRD Part: 0.5 mg BI 425809 | Participants received a single dose of oral solution containing 0.5 milligrams (mg) of BI 425809. | 0 | 6 | 1 | 6 |
| EG002 | SRD Part: 1 mg BI 425809 | Participants received a single dose of oral solution containing 1 milligram (mg) of BI 425809. | 0 | 6 | 2 | 6 |
| EG003 | SRD Part: 2 mg BI 425809 | Participants received a single dose of oral solution containing 2 milligrams (mg) of BI 425809. | 0 | 6 | 3 | 6 |
| EG004 | SRD Part: 5 mg BI 425809 | Participants received a single dose of oral solution containing 5 milligrams (mg) of BI 425809. | 0 | 6 | 5 | 6 |
| EG005 | SRD Part: 10 mg BI425809 | Participants received a single dose of oral solution containing 10 milligrams (mg) of BI 425809. | 0 | 6 | 3 | 6 |
| EG006 | SRD Part: 25 mg BI 425809 | Participants received a single dose of oral solution containing 25 milligrams (mg) of BI 425809. | 0 | 6 | 5 | 6 |
| EG007 | SRD Part: 50 mg BI 425809 | Participants received a single dose of oral solution containing 50 milligrams (mg) of BI 425809. | 0 | 6 | 5 | 6 |
| EG008 | SRD Part: 100 mg BI 425809 | Participants received a single dose of oral solution containing 100 milligrams (mg) of BI 425809. | 0 | 6 | 4 | 6 |
| EG009 | SRD Part: 150 mg BI 425809 | Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809. | 0 | 6 | 6 | 6 |
| EG010 | BA/FE Part: Tablet Without Food | Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R). | 0 | 11 | 4 | 11 |
| EG011 | BA/FE Part: Tablet With Food | Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1). | 0 | 11 | 1 | 11 |
| EG012 | BA/FE Part: Oral Solution Without Food | Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2). | 0 | 11 | 6 | 11 |
| Rhinitis | Infections and infestations | 17.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | 17.1 | Systematic Assessment |
|
| Nervousness | Psychiatric disorders | 17.1 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | 17.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | 17.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | 17.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | 17.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | 17.1 | Systematic Assessment |
|
| Chromatopsia | Eye disorders | 17.1 | Systematic Assessment |
|
| Photopsia | Eye disorders | 17.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | 17.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | 17.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | 17.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | 17.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 17.1 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | 17.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 17.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 17.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 17.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 17.1 | Systematic Assessment |
|
| Skin induration | Skin and subcutaneous tissue disorders | 17.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 17.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | 17.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | 17.1 | Systematic Assessment |
|
| Myalgia intercostal | Musculoskeletal and connective tissue disorders | 17.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | 17.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | 17.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | 17.1 | Systematic Assessment |
|
| Fatigue | General disorders | 17.1 | Systematic Assessment |
|
| Visual field tests abnormal | Investigations | 17.1 | 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
| The data presented was derived from an analysis of variance (ANOVA) on the logarithmic scale, with 'sequence', 'period', and 'treatment' as fixed effects, and 'participants within sequences' as a random effect. Confidence intervals were calculated based on the residual error from the ANOVA. Quantities were back-transformed to the original scale. No hypothesis was tested. | Ratio of adjusted geometric means | 142.10 | 2-Sided | 90 | 128.264 | 157.434 | Adjusted geometric mean ratio [%] = Tablet With Food/Tablet Without Food*100. Intra-matched pair geometric coefficient of variation (gCV) [%] = 13.3 | Other |
| The data presented was derived from an analysis of variance (ANOVA) on the logarithmic scale, with 'sequence', 'period', and 'treatment' as fixed effects, and 'participants within sequences' as a random effect. Confidence intervals were calculated based on the residual error from the ANOVA. Quantities were back-transformed to the original scale. No hypothesis was tested. | Ratio of adjusted geometric means | 125.13 | 2-Sided | 90 | 114.09 | 137.24 | Adjusted geometric mean ratio [%] = Tablet With Food/Tablet Without Food*100. Intra-matched pair geometric coefficient of variation (gCV) [%] = 12.0 | Other |