Clinical trial NCT04447261: A Study to Test How Well Different Doses of BI 1356225 Are Tolerated by Men and Women With Obesity or Overweight
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-06-25
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: The percentage of subjects with drug-related adverse events
timeFrame: Up to 40 days
Secondary outcomes:
measure: 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)
timeFrame: Up to 35 days
measure: Cmax,1 (maximum measured concentration of BI 1356225 in plasma after administration of the first dose)
timeFrame: Up to 35 days
measure: 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)
timeFrame: Up to 35 days
measure: 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)
timeFrame: Up to 35 days
measure: AUC0-tz (area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point)
timeFrame: Up to 35 days
measure: AUC0-tz (area under the concentration-time curve of celecoxib in plasma over the time interval from 0 to the last quantifiable data point)
timeFrame: Up to 35 days
measure: Cmax (maximum measured concentration of midazolam in plasma)
timeFrame: Up to 35 days
measure: Cmax (maximum measured concentration of celecoxib in plasma)
timeFrame: Up to 35 days
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: CRS Clinical Research Services Mannheim GmbH
Study officials:
References: