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

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: BI 1356225; Drug: Placebo

• Registration Number: NCT04447261
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-25
• Study Start: 2020-06-30
• Primary Completion: 2021-04-25
• Study Completion: 2021-04-25
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
BI 1356225	BI 1356225	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
The percentage of subjects with drug-related adverse events	Up to 40 days

Secondary Outcome Measures

Name	Time	Method
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
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
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
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
Cmax (maximum measured concentration of celecoxib in plasma)	Up to 35 days

Trial Locations

Locations (1)

CRS Clinical Research Services Mannheim GmbH; 🇩🇪 Mannheim, Germany