Single Rising Dose Study of BI 207127 NA in Healthy Male Asian Volunteers and Single Dose Study of BI 207127 NA in Healthy Male Caucasian Volunteers

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01347086

First received: May 3, 2011

Last updated: November 16, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 3, 2011

Last Updated Date

November 16, 2011

Start Date ^ICMJE

May 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01347086 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Tmax (time from dosing to maximum measured concentration) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Single Rising Dose Study of BI 207127 NA in Healthy Male Asian Volunteers and Single Dose Study of BI 207127 NA in Healthy Male Caucasian Volunteers

Official Title ^ICMJE

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses (400mg, 800mg, 1200mg) of BI 207127 NA in Healthy Male Asian Volunteers and Single Oral Dose (1200 mg) of BI 207127 NA in Healthy Male Caucasian Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Group)

Brief Summary

The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and Caucasian healthy male volunteers administered BI 207127 NA.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Matching placebo (low dose)
single dose of matching placebo
Drug: BI 207127 NA (medium dose)
Single does of BI 207127 NA
Drug: BI 207127 NA (low dose)
single dose of BI 207127 NA
Drug: Matching placebo (medium dose)
Single dose of matching placebo
Drug: BI 207127 NA (high dose)
Single dose of BI 207127 NA
Drug: Matching placebo (high dose)
Single dose of matching placebo

Study Arm (s)

Experimental: BI 207127 NA (low dose)
Single dose of BI 207127 NA

Intervention: Drug: BI 207127 NA (low dose)
Placebo Comparator: Matching placebo (low dose)
Single dose of matching placebo

Intervention: Drug: Matching placebo (low dose)
Experimental: BI 207127 NA (medium dose)
Single dose of BI 207127 NA

Intervention: Drug: BI 207127 NA (medium dose)
Placebo Comparator: Matching placebo (medium dose)
Single dose of matching placebo

Intervention: Drug: Matching placebo (medium dose)
Experimental: BI 207127 NA (high dose)
Single dose of BI 207127 NA

Intervention: Drug: BI 207127 NA (high dose)
Placebo Comparator: Matching placebo (high dose)
Single dose of matching placebo

Intervention: Drug: Matching placebo (high dose)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Healthy male volunteers
Chinese ethnicity or Japanese ethnicity or Caucasian
Body Mass Index (BMI) = 18.5 and BMI =25 kg/m2 for Japanese and Chinese, BMI =18.5 and BMI = 29.9 kg/m2 for Caucasians

Exclusion criteria:

Any finding of the medical examination (including Blood pressure(BP), Pulse rate (PR) and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial

Gender

Male

Ages

20 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01347086

Other Study ID Numbers ^ICMJE

1241.8

Has Data Monitoring Committee

Not Provided

Responsible Party

Boehringer Ingelheim Pharmaceuticals

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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