Healthy
Conditions
Brief summary
The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of BI 3000202. The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3000202 formulation.
Interventions
DRUGBI 3000202
BI 3000202
Placebo matching BI 3000202
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
SRD part: single blinded FE part: open-label
Intervention model description
The SRD part of the trial is designed as blinded to subjects, randomised, and placebo-controlled within parallel dose groups. In the FE part, subjects participate in a randomised, open-label, two-way crossover trial part with two treatment periods.
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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)), 12-lead electrocardiogram (ECG), and clinical laboratory tests without any clinically significant abnormalities 2. Age of 18 to 45 years (inclusive) 3. Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive) 4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Exclusion criteria
1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator 2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm) 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator 5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) 7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders 8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SRD Part: Number of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator | From drug administration on Day 1 plus REP of 48 hours, up to 2 days. | Number of any treatment-emergent adverse event assessed as drug-related by the investigator. Percentages were calculated using the total number of participants per treatment as denominator. MedDRA version 26.1 was used for reporting. All adverse events occurring up to 48 hours (2 days) after drug administration were assigned to treatment. Medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history. |
| FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24) | Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration | Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 24 hours (AUC0-24). The AUC0-24 endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model. The ANOVA model accounted for the random effect 'participants within sequences' and fixed effects 'sequence' 'period' and 'treatment'. |
| FE Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax) | Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration | Maximum measured concentration of BI 3000202 in plasma (Cmax). The Cmax endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model. The ANOVA model accounted for the random effect 'participants within sequences' and the fixed effects 'sequence' 'period' and 'treatment'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SRD Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24) | Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration | Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 24 hours (AUC0-24) was analyzed descriptively. |
| SRD Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax) | Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration | Maximum measured concentration of BI 3000202 in plasma was analyzed descriptively. |
| FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to Infinity (AUC0-∞) | Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration | Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to infinity (AUC0-∞). The AUC0-∞ endpoint was log-transformed (natural logarithm) prior to fitting the Analysis of Variance (ANOVA) model. The ANOVA model accounted for the random effect 'participants within sequences' and the fixed effects 'sequence' 'period' and 'treatment'. |
Countries
Germany
Participant flow
Recruitment details
This trial consisted of two parts, a single rising dose (SRD) part and food effect (FE) part in healthy men. The SRD part was a randomized, single-blind, and placebo-controlled trial, while the FE part was randomized, open-label, single dose, and two-way cross-over. The subjects in the SRD part were mutually exclusive with those in the FE part.
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 | 32.1 Years STANDARD_DEVIATION 7.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| 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 | 66 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 14 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 3 / 14 | 0 / 6 | 0 / 6 | 1 / 6 | 0 / 6 | 0 / 6 | 1 / 6 | 0 / 6 | 2 / 12 | 1 / 12 |
| serious Total, serious adverse events | 0 / 14 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 | 0 / 12 |
Outcome results
None listed