Safety and Pharmacokinetics of Single Rising Oral Doses of BI 224436 ZW in Healthy Male Volunteers.

July 7, 2014 updated by: Boehringer Ingelheim

Safety and Pharmacokinetics of Single Rising Oral Doses of BI 224436 ZW at 6.2 mg, 12.5 mg, 25 mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg and 1200 mg Dose Levels in Healthy Male Volunteers (Randomized, Double-blind, Placebo-controlled Within Dose Groups)

To investigate safety and pharmacokinetics of BI 224436 ZW

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Healthy males
  2. Age ≥21 and Age ≤50 years
  3. Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
  4. Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation.

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. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  4. Surgery of the gastrointestinal tract (except appendectomy)
  5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  6. History of relevant orthostatic hypotension, fainting spells or blackouts
  7. HIV infection and other chronic or relevant acute infections
  8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  9. 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
  10. Use of drugs which might reasonably influence the results of the trial within 10 days prior to administration or during the trial
  11. Participation in another trial with an investigational drug within one month prior to administration or during the trial
  12. Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
  13. Inability to refrain from smoking on trial days
  14. Alcohol abuse (more than 60 g/day)
  15. Drug abuse
  16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  17. Excessive physical activities (within one week prior to administration or during the treatment period)
  18. Any laboratory value outside the reference range that is of clinical relevance
  19. A baseline prolongation of QT/QTc interval (e.g., a QTc interval ≥450 ms)
  20. A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  21. Bradycardia (PR <60 beats/min)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Experimental: BI 224436

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
maximum measured concentration of the analyte in plasma
Time Frame: up to 72 hours
up to 72 hours
area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24
Time Frame: up to 24 hours
up to 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
Time Frame: up to 72 hours
up to 72 hours
minimum observed concentration at 24 hours
Time Frame: up to 24 hours
up to 24 hours
terminal half-life of the analyte in plasma
Time Frame: up to 72 hours
up to 72 hours
time from dosing to maximum measured concentration of the analyte in plasma
Time Frame: up to 72 hours
up to 72 hours
apparent clearance of the analyte in plasma
Time Frame: up to 72 hours
up to 72 hours
apparent volume of distribution during the terminal phase λz
Time Frame: up to 72 hours
up to 72 hours
apparent volume of distribution
Time Frame: up to 72 hours
up to 72 hours
mean residence time of the analyte in the body after single oral administration
Time Frame: up to 72 hours
up to 72 hours
terminal rate constant in plasma
Time Frame: up to 72 hours
up to 72 hours
the last measurable concentration in the concentration-time profile
Time Frame: up to 72 hours
up to 72 hours
the extrapolated Area under the curve from the time of the last measurable concentration in the concentration-time profile to infinity
Time Frame: up to 72 hours
up to 72 hours
the percentage of the Area under the concentration-time curve until infinity, that is determined by extrapolation
Time Frame: up to 72 hours
up to 72 hours
amount of analyte that is eliminated in urine from the time point t0 to time point t4
Time Frame: up to 4 hours
up to 4 hours
amount of analyte that is eliminated in urine from the time point t4 to time point t8
Time Frame: from 4 to 8 hours
from 4 to 8 hours
amount of analyte that is eliminated in urine from the time point t8 to time point t12
Time Frame: from 8 to 12 hours
from 8 to 12 hours
amount of analyte that is eliminated in urine from the time point t12 to time point t24
Time Frame: from 12 to 24 hours
from 12 to 24 hours
fraction of analyte eliminated in urine from time point t0 to time point t24
Time Frame: up to 24 hours
up to 24 hours
renal clearance of the analyte from the time point t0 until the time point t24
Time Frame: up to 24 hours
up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

July 7, 2014

First Submitted That Met QC Criteria

July 7, 2014

First Posted (Estimate)

July 8, 2014

Study Record Updates

Last Update Posted (Estimate)

July 8, 2014

Last Update Submitted That Met QC Criteria

July 7, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 1277.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on BI 224436

3
Subscribe