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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04447261
• Other study ID #: 1427-0002
• Secondary ID: 2020-000342-34
• Status: Completed
• Phase: Phase 1
• Start date: June 30, 2020
• Est. completion date: April 25, 2021

Study information

• Verified date: May 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: April 25, 2021
• Est. primary completion date: April 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• BI 1356225
BI 1356225
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Mannheim GmbH	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of subjects with drug-related adverse events		Up to 40 days
Secondary	AUCt, 1 (area under the concentration-time curve of BI 1356225 in plasma over a uniform dosing interval t after administration of the first dose)		Up to 35 days
Secondary	Cmax,1 (maximum measured concentration of BI 1356225 in plasma after administration of the first dose)		Up to 35 days
Secondary	AUCt,ss (area under the concentration-time curve of BI 1356225 in plasma at steady state over a uniform dosing interval t after administration of the last dose)		Up to 35 days
Secondary	Cmax,ss (maximum measured concentration of BI 1356225 in plasma at steady state over a uniform dosing interval t after administration of the last dose)		Up to 35 days
Secondary	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
Secondary	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
Secondary	Cmax (maximum measured concentration of midazolam in plasma)		Up to 35 days
Secondary	Cmax (maximum measured concentration of celecoxib in plasma)		Up to 35 days

External Links

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