Healthy
Conditions
Brief summary
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
Interventions
DRUGBI 425809 PfOS
BI 425809 as a powder for an oral solution (PfOS)
DRUGPlacebo PfOS
Placebo as a powder for an oral solution (PfOS)
DRUGBI 425809 tablet
BI 425809 as a tablet
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
Part 1 of this study was conducted as a sequential assignment, while Part 2 of this study was conducted as a crossover assignment.
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects * Age 18 to 45 years (incl.) * Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.) * Subject must be able to understand and comply with study requirements
Exclusion criteria
* Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and judged clinically relevant by the investigator * Repeated measurement of systolic blood pressure \<90 or \>140 mmHg, or diastolic blood pressure \<50 or \>90 mmHg, or pulse rate \<50 or \>90 * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance * Any evidence of a concomitant disease judged clinically relevant by the investigator * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s) * Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Drug-related Adverse Events (AE) | 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. | Number of participants with drug-related Adverse Events (AE). Drug-relatedness was assessed by the investigator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SRD Part: Maximum Concentration of BI 425809 in Plasma (Cmax) | 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. | Maximum measured concentration of BI 425809 in plasma (Cmax) in the Single Rising Dose (SRD) part of the trial is reported. |
| BA/FE Part: Maximum Concentration of BI 425809 in Plasma (Cmax) | 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. | Maximum measured concentration of BI 425809 in plasma (Cmax) in the bioavailability/food effect (BA/FE) part of the trial is reported. |
| SRD Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞)) | 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. | 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. |
| 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-∞)) | 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. | 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. |
Countries
Germany
Contacts
STUDY_CHAIRBoehringer Ingelheim
Boehringer Ingelheim
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 31.5 years STANDARD_DEVIATION 10.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 83 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| other Total, other adverse events | 5 / 18 | 1 / 6 | 2 / 6 | 3 / 6 | 5 / 6 | 3 / 6 | 5 / 6 | 5 / 6 | 4 / 6 | 6 / 6 | 4 / 11 | 1 / 11 | 6 / 11 |
| serious Total, serious adverse events | 0 / 18 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 11 | 0 / 11 | 0 / 11 |
Outcome results
None listed