Obesity
Conditions
Brief summary
The primary objective of this trial is to investigate safety and tolerability of BI 1356225 in male and female patients with overweight and obesity following oral administration of multiple rising doses per day over 28 days. Secondary objectives are the exploration of pharmacokinetics (PK) of BI 1356225 after multiple oral dosing. Additionally, the relative bioavailability (BA) of midazolam and celecoxib in the presence and absence of BI 1356225 will be evaluated
Interventions
DRUGBI 1356225
BI 1356225
DRUGPlacebo
Placebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients, age ≥ 18 and \< 70 * Body Mass Index ≥ 27 kg/m2 and \< 40 kg/m2 at screening * Stable body weight (defined as no more than 5% change) within 3 months prior to screening * further inclusion criteria apply
Exclusion criteria
* Females of childbearing potential * Clinically relevant concomitant disease per investigator judgment * Any condition or disease requiring permanent pharmacotherapy during the trial * Any history of lifetime suicidal behaviour and any suicidal ideation of type 2 - 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 12 months * further
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects with drug-related adverse events | Up to 40 days |
Secondary
| Measure | Time frame |
|---|---|
| Cmax,1 (maximum measured concentration of BI 1356225 in plasma after administration of the first dose) | Up to 35 days |
| AUCτ,ss (area under the concentration-time curve of BI 1356225 in plasma at steady state over a uniform dosing interval τ after administration of the last dose) | Up to 35 days |
| Cmax,ss (maximum measured concentration of BI 1356225 in plasma at steady state over a uniform dosing interval τ after administration of the last dose) | Up to 35 days |
| AUCτ, 1 (area under the concentration-time curve of BI 1356225 in plasma over a uniform dosing interval τ after administration of the first dose) | Up to 35 days |
| AUC0-tz (area under the concentration-time curve of celecoxib in plasma over the time interval from 0 to the last quantifiable data point) | Up to 35 days |
| Cmax (maximum measured concentration of midazolam in plasma) | Up to 35 days |
| Cmax (maximum measured concentration of celecoxib in plasma) | Up to 35 days |
| AUC0-tz (area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point) | Up to 35 days |
Countries
Germany
Outcome results
None listed