A Study to Test How Well Different Doses of BI 1356225 Are Tolerated by Men and Women With Obesity or Overweight

Study Overview
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Brief Summary
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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

Official Title
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Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1356225 (Randomised, Placebo-controlled, Blinded Within Dose Groups) and Evaluation of Midazolam and Celecoxib Interaction (Nested, Open, Fixed-sequence, Intra-individual Comparison) in Patients With Overweight or Obesity

Conditions
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Obesity

Intervention / Treatment
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* Drug: BI 1356225
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 1356225<br> | Drug: BI 1356225<br>* BI 1356225<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of subjects with drug-related adverse events |  | Up to 40 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |