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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
ClinicalTrials.gov Identifier:
NCT01347086
First received: May 3, 2011
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Matching placebo (low dose)
Drug: BI 207127 NA (medium dose)
Drug: BI 207127 NA (low dose)
Drug: Matching placebo (medium dose)
Drug: BI 207127 NA (high dose)
Drug: Matching placebo (high dose)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Vital signs: blood pressure (BP), pulse rate (PR) [ Time Frame: Baseline, 3 days of treatment, end of trial ] [ Designated as safety issue: No ]
  • 12-lead electrocardiogram (ECG) [ Time Frame: Baseline, 3 days of treatment, end of trial ] [ Designated as safety issue: Yes ]
  • Clinical laboratory tests (haematology, clinical chemistry and urinalysis) [ Time Frame: Baseline, 3 days of treatment, end of trial ] [ Designated as safety issue: No ]
  • Incidence and intensity of Adverse events [ Time Frame: up to 47 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: May 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 207127 NA (low dose)
Single dose of BI 207127 NA
Drug: BI 207127 NA (low dose)
single dose of BI 207127 NA
Placebo Comparator: Matching placebo (low dose)
Single dose of matching placebo
Drug: Matching placebo (low dose)
single dose of matching placebo
Experimental: BI 207127 NA (medium dose)
Single dose of BI 207127 NA
Drug: BI 207127 NA (medium dose)
Single does of BI 207127 NA
Placebo Comparator: Matching placebo (medium dose)
Single dose of matching placebo
Drug: Matching placebo (medium dose)
Single dose of matching placebo
Experimental: BI 207127 NA (high dose)
Single dose of BI 207127 NA
Drug: BI 207127 NA (high dose)
Single dose of BI 207127 NA
Placebo Comparator: Matching placebo (high dose)
Single dose of matching placebo
Drug: Matching placebo (high dose)
Single dose of matching placebo

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Healthy male volunteers
  2. Chinese ethnicity or Japanese ethnicity or Caucasian
  3. 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:

  1. Any finding of the medical examination (including Blood pressure(BP), Pulse rate (PR) and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
  2. Any evidence of a clinically relevant concomitant disease
  3. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347086

Locations
Korea, Republic of
1241.8.8201 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01347086     History of Changes
Other Study ID Numbers: 1241.8
Study First Received: May 3, 2011
Last Updated: October 30, 2013
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on November 24, 2014