- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02183662
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
Intervention / Treatment
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:
- Healthy males
- Age ≥21 and Age ≤50 years
- Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
- 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:
- 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
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- HIV infection and other chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- 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
- Use of drugs which might reasonably influence the results of the trial within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within one month prior to administration or during the trial
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the treatment period)
- Any laboratory value outside the reference range that is of clinical relevance
- A baseline prolongation of QT/QTc interval (e.g., a QTc interval ≥450 ms)
- A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- 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.
Sponsor
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.
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