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Safety, Tolerability and Pharmacokinetics of BI 409306 Tablets in Healthy Asian Male Volunteers

NCT ID: NCT01841112

Last Updated: 2024-06-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-22

Study Completion Date

2013-07-18

Brief Summary

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Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 409306 tablets in healthy Chinese and Japanese male volunteers of a known genotype as specified in the study protocol.

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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

Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment

BI-409306 25 milligram (mg) SD

Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

Group Type EXPERIMENTAL

BI-409306 25 milligram (mg) SD

Intervention Type DRUG

Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

BI-409306 50 mg SD

Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

Group Type EXPERIMENTAL

BI-409306 50 mg SD

Intervention Type DRUG

Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

BI-409306 100 mg SD

Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

Group Type EXPERIMENTAL

BI-409306 100 mg SD

Intervention Type DRUG

Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

BI-409306 100 mg MDBI-409306 100 mg SD & MD

Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first does of multipled dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes.

Group Type EXPERIMENTAL

BI-409306 100 mg MD

Intervention Type DRUG

Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9

Interventions

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Placebo

Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment

Intervention Type DRUG

BI-409306 25 milligram (mg) SD

Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

Intervention Type DRUG

BI-409306 50 mg SD

Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

Intervention Type DRUG

BI-409306 100 mg SD

Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

Intervention Type DRUG

BI-409306 100 mg MD

Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male Chinese and Japanese volunteers
2. Age between 20 and 45 years
3. BMI between 18.5 and 25 kg/m2 (Body Mass Index)
4. Known genotype as specified in the study protocol
5. Subjects must be able to understand and comply with study requirements

Exclusion Criteria

1\. Any deviation from healthy condition
Minimum Eligible Age

20 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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1289.4.8201 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

Countries

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South Korea

Related Links

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https://www.mystudywindow.com

Related Info

Other Identifiers

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1289.4

Identifier Type: -

Identifier Source: org_study_id

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