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

NCT02254057 | Completed Phase 1

• 1 other identifier: 1192.1
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to assess the tolerability of BIBT 986 BS after intravenous infusions of 0.1, 0.3, 1.0, 2.5, 5.0, and 10 mg, to assess the pharmacokinetics of BIBT 986 BS after intravenous infusion and to assess the effect of BIBT 986 BS on blood coagulation parameters

Conditions

Healthy

Outcome Measures

Primary Outcomes (18)

• 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)

  up to 48 hours after start of infusion

• 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)

  up to 48 hours after start of infusion

• C29 (plasma concentration of BIBT 986 BS at the end of infusion)

  29 minutes after start of infusion

• t1/2 (Terminal half-life of the analyte in plasma after single dose administration)

  up to 48 hours after start of infusion

• CL (Total clearance of the analyte in plasma following intravascular administration)

  up to 48 hours after start of infusion

• Vss (Apparent volume of distribution at steady state following intravascular administration)

  up to 48 hours after start of infusion

• urinary excretion of BIBT 986 BS

  up to 48 hours after start of infusion

• CLR (Renal clearance of the analyte in plasma following intravascular administration)

  up to 48 hours after start of infusion

• MRT (Mean residence time of drug molecules in the body after intravascular administration)

  up to 48 hours after start of infusion

• Change in activated partial thromboplastin time (aPTT)

  up to 48 hours after start of infusion

• Change in International Normalised Ratio (INR)

  up to 48 hours after start of infusion

• Change in ecarin clotting time (ECT)

  up to 48 hours after start of infusion

• Change in thrombin time (TT)

  up to 48 hours after start of infusion

• Number of patients with clinically significant findings in vital signs

  pulse rate, blood pressure

  up to 48 hours after start of infusion

• Number of patients with clinically significant findings in electrocardiogram

  up to 48 hours after start of infusion

• Number of patients with clinically significant findings in laboratory tests

  up to 48 hours after start of infusion

• Number of patients with adverse events

  up to 48 hours after start of infusion

• Number of patients with histamine in blood

  up to 48 hours after start of infusion

Study Arms (2)

BIBT 986 BS - single rising dose

EXPERIMENTAL

Drug: BIBT 986 BS - single rising dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIBT 986 BS - single rising dose DRUG

BIBT 986 BS - single rising dose

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Any bleeding disorder including prolonged or habitual bleeding
• History of other hematologic disease, cerebral bleeding (e.g. after a car accident), commotio cerebri
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Seasonal rhinitis
• Thrombocytes \< 150000/μl
• Intake of drugs with a long half-life (\> 24 hours) (\< 1 month prior to administration or during the trial)
• Use of any drugs, which might influence the results of the trial (\< 10 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 1, 2014
• Study Start: July 1, 2002
• Primary Completion: October 1, 2002
• Last Updated: October 1, 2014

Record last verified: 2014-09