Tolerability and Pharmacokinetics/-Dynamics of BIBT 986 BS in Healthy Male Subjects

September 30, 2014 updated by: Boehringer Ingelheim

Tolerability and Pharmacokinetics/-Dynamics of 0.5 mg and 1.0 mg (Actual 0.8 mg) of BIBT 986 BS Per Hour Given as IV Infusion Over 32 Hours in Healthy Male Subjects. Placebo Controlled, Double Blind Randomised at Each Dose Level

Study to assess the tolerability of an intravenous infusion of 0.5 and 1.0 mg (actual 0.8 mg) BIBT 986 BS per hour over 32 hours as well as pharmacokinetics and the effect on blood coagulation parameters

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male subjects as determined by results of screening
  • Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
  • Age >= 18 and <= 55 years
  • BMI >= 18.5 and <= 29.9 kg/m2

Exclusion Criteria:

  • Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
  • Surgery of gastrointestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • Relevant history of orthostatic hypotension, fainting spells or blackouts
  • Abnormal PT, TT, aPTT (must be within the normal range after no more than one repeated test), thrombocytes < 150000/μl (two repeats of the first test)
  • Evidence of hematuria either macroscopically detectable or microscopic on urinalysis (normal microscopic results after no more than one repeated test)
  • Evidence of blood dyscrasia, hemorrhagic diathesis, severe thrombocytopenia, cerebrovascular hemorrhage, bleeding tendencies associated with active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary tract or any disease or condition with hemorrhagic tendencies (e.g. cerebral aneurysm, dissecting aorta, Central nervous system (CNS) trauma, retinopathy, nephrolithiasis)
  • Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding (e.g. spinal puncture, lumbar block anaesthesia, surgery of CNS or eye or surgery resulting in large open surfaces) within 14 days before or after drug administration of this clinical trial
  • Occult blood in 1 of 3 subsequent faecal samples collected for the pre-study examination
  • Chronic or relevant acute infections
  • History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • Intake of drugs with a long half-life (> 24 hours) (< 1 month prior to administration or during the trial)
  • Use of any drugs, within 14 days prior to administration or during the trial
  • Participation in another trial with an investigational drug (< 2 months prior to administration or during trial)
  • Smoker (> 10 cigarettes or >3 cigars or >3 pipes/day)
  • Alcohol abuse (> 60 g/day)
  • Drug abuse
  • Blood donation or loss > 400 mL, < 1 month prior to administration or during the trial
  • Excessive physical activities < 5 days prior to administration of study drug or during trial
  • Clinically relevant laboratory abnormalities
  • Veins unsuited for i.v. puncture and administration of prolonged infusions on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture, etc.)

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Experimental: BIBT 986 BS - low
Drug: BIBT 986 BS - low
Experimental: BIBT 986 BS - high
Drug: BIBT 986 BS - high

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax (maximum measured concentration of the analyte in plasma)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
CT (concentration of the analyte at the end of drug infusion)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
Css (steady state concentration of the analyte in plasma following a constant rate infusion)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
Tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
t1/2 (Terminal half-life of the analyte in plasma after single dose administration)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration after single dose administration)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
λz (terminal rate constant of the analyte in plasma)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
MRTinf (mean residence time of the analyte in the body after intravenous infusion)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
CL (Total clearance of the analyte in plasma following intravascular administration)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
Vss (Apparent volume of distribution at steady state following intravascular administration)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
Vz (apparent volume of distribution during the terminal phase λz following intravascular administration)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
Amount of parent drug eliminated in urine (Ae)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
Change in activated partial thromboplastin time (aPTT)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
Change in prothrombin time (PT)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
Change in ecarin clotting time (ECT)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
Change in thrombin time (TT)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
Number of subjects with adverse events
Time Frame: up to 4 days
up to 4 days
Number of subjects with clinically significant changes in vital signs
Time Frame: up to 4 days
Pulse rate, systolic & diastolic blood pressure
up to 4 days
Change in International Normalised Ratio (INR)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
Fraction of administered drug excreted unchanged in urine (fe)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
CLR (renal clearance of the analyte in plasma following intravascular administration)
Time Frame: up to 48 hours post dose
up to 48 hours post dose

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1192.2

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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