Safety, Pharmacodynamics, and Pharmacokinetics of BIBT 1011 BS in Healthy Subjects

NCT02182037 | Completed Phase 1

• 1 other identifier: 1193.1
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to assess safety, pharmacokinetics and the effect of BIBT 986 BS, given as BIBT 1011 BS, on coagulation parameters.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Determination of activated partial thromboplastin time (aPTT)

  Pre-dose, up to 48 hours after start of treatment

• Determination of international normalized ration (INR)

  Pre-dose, up to 48 hours after start of treatment

Secondary Outcomes (13)

• Determination of thrombin time (TT)

  Pre-dose, up to 48 hours after start of treatment

• Determination of ecarin clotting time (ECT)

  Pre-dose, up to 48 hours after start of treatment

• Assessment of plasma concentration time profiles of BIBT 986 BS

  Pre-dose, up to 48 hours after start of treatment

• Maximum concentration of BIBT 986 BS in plasma (Cmax)

  Pre-dose, up to 48 hours after start of treatment

• Area under the concentration time curve for BIBT 986 BS (AUC)

  Pre-dose, up to 48 hours after start of treatment

Study Arms (2)

BIBT 1011 BS

EXPERIMENTAL

Drug: Single rising doses of BIBT 1011 BS

BIBT 1011 BS placebo

PLACEBO COMPARATOR

Drug: BIBT 1011 BS placebo

Interventions

Single rising doses of BIBT 1011 BS DRUG

BIBT 1011 BS

BIBT 1011 BS placebo DRUG

BIBT 1011 BS placebo

Eligibility Criteria

• Age: 18 Years - 45 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 ≤ 45 years
• Body Mass Index ≥ 18.5 and ≤ 29.9 kg/m2

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
• Chronic or relevant acute infections
• History of
• allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• any bleeding disorder including prolonged or habitual bleeding
• other hematologic disease
• cerebral bleeding (e.g. after a car accident)
• commotio cerebri
• Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
• Use of any drugs which might 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 2 months prior to administration or during trial
• Smoker (\>10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days

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: July 2, 2014
• First Posted: July 8, 2014
• Study Start: August 1, 2001
• Primary Completion: September 1, 2001
• Last Updated: July 14, 2014

Record last verified: 2014-07