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A Study in Healthy Men to Test How Different Doses of BI 3000202 Are Tolerated and How Food Influences the Amount of BI 3000202 in the Blood

NCT ID: NCT05945888

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-25

Study Completion Date

2023-11-13

Brief Summary

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The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of BI 3000202.

The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3000202 formulation.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The SRD part of the trial is designed as blinded to subjects, randomised, and placebo-controlled within parallel dose groups.

In the FE part, subjects participate in a randomised, open-label, two-way crossover trial part with two treatment periods.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
SRD part: single blinded FE part: open-label

Study Groups

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SRD part: Treatment group

Group Type EXPERIMENTAL

BI 3000202

Intervention Type DRUG

BI 3000202

SRD part: Placebo group

Group Type PLACEBO_COMPARATOR

Placebo matching BI 3000202

Intervention Type DRUG

Placebo matching BI 3000202

FE part: Treatment sequence reference (R) - test (T)

Group Type EXPERIMENTAL

BI 3000202

Intervention Type DRUG

BI 3000202

FE part: Treatment sequence test (T) - reference (R)

Group Type EXPERIMENTAL

BI 3000202

Intervention Type DRUG

BI 3000202

Interventions

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BI 3000202

BI 3000202

Intervention Type DRUG

Placebo matching BI 3000202

Placebo matching BI 3000202

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests without any clinically significant abnormalities
2. Age of 18 to 45 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion Criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Humanpharmakologisches Zentrum Biberach

Biberach, , Germany

Site Status

Countries

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Germany

Related Links

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https://www.mystudywindow.com

Related Info

Other Identifiers

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2022-502424-43-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

1509-0001

Identifier Type: -

Identifier Source: org_study_id