Tolerability of BIBR 953 ZW IV and Bioavailability of BIBR 1048 Tablet and Solution in Healthy Males

NCT02170584 | Completed Phase 1

• 1 other identifier: 1160.5
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Two substudies to assess (1) the tolerability of BIBR 953 ZW intravenous infusion at 0.1, 1 and 5 mg BIBR 953 ZW and (2) the absolute bioavailability of 100mg BIBR 1048 administered as 'acid free' tablet formulation (TF1) and (3) the bioavailability of the 100 mg tablet of BIBR 1048 relative to the tartaric acid solution of 100 mg dose strength and (4) the absolute bioavailability of the 100 mg tartaric acid solution of BIBR 1048 MS.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• AUC0-inf (Area under the plasma concentration-time curve extrapolated to infinity)

  up to 48 hours after drug administration

• AUC0-tf (Area under the plasma concentration-time curve up to the last quantifiable plasma concentration)

  up to 48 hours after drug administration

• Cmax (Maximum plasma concentration after oral administration)

  up to 48 hours after drug administration

• Cumulative urinary excretion of BIBR 953 ZW administered intravenously

  up to 48 hours after drug administration

Secondary Outcomes (18)

• changes in activated partial thromboplastin time (aPTT )

  up to 48 hours after drug administration

• changes in prothrombin time (PT)

  up to 48 hours after drug administration

• C29 (Plasma concentration of BIBR 953 ZW at 29 minutes after the start of the 30 min. infusion)

  29 minutes after start of infusion

• t1/2 (terminal half-life)

  up to 48 hours after infusion

• CLtot (total clearance of drug from plasma)

  up to 48 hours after infusion

Study Arms (4)

BIBR 953 ZW IV

EXPERIMENTAL

Drug: BIBR 953 ZW IV

BIBR 1048 MS oral solution

ACTIVE COMPARATOR

Drug: BIBR 1048 MS oral solution

BIBR 1048 MS tablet

EXPERIMENTAL

Drug: BIBR 1048 MS tablet

BIBR 953 ZW IV Placebo

PLACEBO COMPARATOR

Drug: BIBR 953 ZW IV Placebo

Interventions

BIBR 953 ZW IV DRUG

BIBR 953 ZW IV

BIBR 1048 MS tablet DRUG

BIBR 1048 MS tablet

BIBR 1048 MS oral solution DRUG

BIBR 1048 MS oral solution

BIBR 953 ZW IV Placebo DRUG

BIBR 953 ZW IV Placebo

Eligibility Criteria

• Age: 18 Years - 50 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 GCP and local legislation
• Age ≥ 18 and ≤ 50 years
• Broca ≥ - 20% and ≤ + 20%

You may not qualify if:

• Any findings 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, immunologic, hormonal disorders
• History of orthostatic hypotension, fainting spells and 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 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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 23, 2014
• Study Start: January 1, 2001
• Primary Completion: March 1, 2001
• Last Updated: June 23, 2014

Record last verified: 2014-06