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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 409306

NCT ID: NCT01611311

Last Updated: 2024-03-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-01

Study Completion Date

2012-08-01

Brief Summary

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The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy young and elderly male and female volunteers following oral administration of repeated rising doses, given once daily over 14 days to young healthy genotyped and elderly healthy male/female volunteers.

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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

DOUBLE

Study Groups

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Placebo (Young subjects)

Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

BI 409306 - 25 milligram (mg) (Young subjects)

Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

Group Type EXPERIMENTAL

BI 409306

Intervention Type DRUG

Film-coated tablet

BI 409306 - 50 milligram (mg) (Young subjects)

Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

Group Type EXPERIMENTAL

BI 409306

Intervention Type DRUG

Film-coated tablet

Placebo (Elderly subjects)

Elderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

BI 409306 - 25 milligram (mg) (Elderly subjects)

Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

Group Type EXPERIMENTAL

BI 409306

Intervention Type DRUG

Film-coated tablet

BI 409306 - 50 milligram (mg) (Elderly subjects)

Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

Group Type EXPERIMENTAL

BI 409306

Intervention Type DRUG

Film-coated tablet

Interventions

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BI 409306

Film-coated tablet

Intervention Type DRUG

Placebo

Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Healthy male/female subjects

Exclusion Criteria

1\. Any relevant deviation from healthy conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

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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1289.17.1 Boehringer Ingelheim Investigational Site

Neuss, , 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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2012-000052-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1289.17

Identifier Type: -

Identifier Source: org_study_id

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