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Single Rising Dose Study With Intravenous Infusion and Subcutaneous Injection of BI 1005273 in Healthy Male Volunteers.

NCT ID: NCT01650155

Last Updated: 2014-10-16

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

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-09-30

Brief Summary

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To investigate the safety and tolerability of BI 1005273 in healthy male volunteers following intravenous (i.v.) infusion of single rising doses and subcutaneous (s.c.) injection. Secondary objectives are the exploration of the pharmacokinetics and early pharmacodynamics of BI 1005273.

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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

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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BI 1005273 i.v.

single dose i.v. infusion

Group Type EXPERIMENTAL

BI 1005273 i.v.

Intervention Type DRUG

infusion

BI 1005273 i.v. Placebo

single dose i.v. infusion (Placebo)

Group Type PLACEBO_COMPARATOR

BI 105273 i.v. Placebo

Intervention Type DRUG

infusion

BI 1005273 s.c.

single dose s.c. injection

Group Type EXPERIMENTAL

BI 1005273 s.c.

Intervention Type DRUG

injection

BI 1005273 s.c. Placebo

single dose s.c. injection (Placebo)

Group Type PLACEBO_COMPARATOR

BI 1005273 s.c. Placebo

Intervention Type DRUG

injection

Interventions

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BI 1005273 s.c.

injection

Intervention Type DRUG

BI 105273 i.v. Placebo

infusion

Intervention Type DRUG

BI 1005273 s.c. Placebo

injection

Intervention Type DRUG

BI 1005273 i.v.

infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Healthy male subjects

Exclusion Criteria

1\. Any 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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1294.1.1 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2011-004987-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1294.1

Identifier Type: -

Identifier Source: org_study_id

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