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Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Oral Doses of BI 1021958 Tablets in Healthy Male Volunteers

NCT ID: NCT01541488

Last Updated: 2013-10-31

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Brief Summary

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Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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BI 1021958

Single rising dose (SRD) part

Group Type EXPERIMENTAL

BI 1021958

Intervention Type DRUG

drinking solution / tablet

BI 1021958 (Food effect)

Food effect part (FE)

Group Type EXPERIMENTAL

BI 1021958

Intervention Type DRUG

tablet

Placebo to BI 1021958

Matching placebo as drinking solution and tablets

Group Type PLACEBO_COMPARATOR

Placebo to BI 1021958

Intervention Type DRUG

SRD part: oral administration in fasted state, FE part: oral administration in fasted state and after standard high fat breakfast

Interventions

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BI 1021958

tablet

Intervention Type DRUG

BI 1021958

drinking solution / tablet

Intervention Type DRUG

Placebo to BI 1021958

SRD part: oral administration in fasted state, FE part: oral administration in fasted state and after standard high fat breakfast

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Healthy male subjects

Exclusion Criteria

1\. Any relevant deviation from healthy conditions
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

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1310.1.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2011-003483-70

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1310.1

Identifier Type: -

Identifier Source: org_study_id