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Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 163538 XX

NCT ID: NCT01587391

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-10-31

Brief Summary

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To investigate safety, tolerability, pharmacokinetics including dose proportionality, and pharmacodynamics of BI 163538 XX within a predefined dose range

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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BI 163538 XX

1 single dose per subject as oral solution

Group Type EXPERIMENTAL

BI 163538 XX

Intervention Type DRUG

1 single dose per subject as oral solution

Placebo to BI 163538 XX

1 single dose per subject as oral solution

Group Type PLACEBO_COMPARATOR

Placebo to BI 163538 XX

Intervention Type DRUG

1 single dose per subject as oral solution

Interventions

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Placebo to BI 163538 XX

1 single dose per subject as oral solution

Intervention Type DRUG

BI 163538 XX

1 single dose per subject as oral solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male subjects
2. overweight or obese

Exclusion Criteria

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

18 Years

Maximum Eligible Age

55 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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1291.1.1 Boehringer Ingelheim Investigational Site

Neuss, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2011-006184-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1291.1

Identifier Type: -

Identifier Source: org_study_id