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

Primary Purpose

Obesity

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

BI 1356225

Placebo

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CRS Clinical Research Services Mannheim GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BI 1356225

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The percentage of subjects with drug-related adverse events

Secondary Outcome Measures

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)

Cmax,1 (maximum measured concentration of BI 1356225 in plasma after administration of the first dose)

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)

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)

AUC0-tz (area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point)

AUC0-tz (area under the concentration-time curve of celecoxib in plasma over the time interval from 0 to the last quantifiable data point)

Cmax (maximum measured concentration of midazolam in plasma)

Cmax (maximum measured concentration of celecoxib in plasma)

Full Information

NCT ID

NCT04447261

First Posted

June 24, 2020

Last Updated

May 18, 2021

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT04447261

Brief Title

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

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

June 30, 2020 (Actual)

Primary Completion Date

April 25, 2021 (Actual)

Study Completion Date

April 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

87 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BI 1356225

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

BI 1356225

Intervention Description

BI 1356225

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

The percentage of subjects with drug-related adverse events

Time Frame

Up to 40 days

Secondary Outcome Measure Information:

Title

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)

Time Frame

Up to 35 days

Title

Cmax,1 (maximum measured concentration of BI 1356225 in plasma after administration of the first dose)

Time Frame

Up to 35 days

Title

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)

Time Frame

Up to 35 days

Title

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)

Time Frame

Up to 35 days

Title

AUC0-tz (area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point)

Time Frame

Up to 35 days

Title

AUC0-tz (area under the concentration-time curve of celecoxib in plasma over the time interval from 0 to the last quantifiable data point)

Time Frame

Up to 35 days

Title

Cmax (maximum measured concentration of midazolam in plasma)

Time Frame

Up to 35 days

Title

Cmax (maximum measured concentration of celecoxib in plasma)

Time Frame

Up to 35 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

CRS Clinical Research Services Mannheim GmbH

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).For more details refer to: http://trials.boehringer-ingelheim.com/

Links:

URL

https://www.mystudywindow.com

Description

Related Info

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

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