BIBR 953 ZW in Healthy Elderly Subjects

NCT02173730 | Completed Phase 1

• 1 other identifier: 1160.10
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the steady state pharmacokinetic profile of BIBR 953 ZW after administration of BIBR 1048 to male and female elderly subjects, to assess pharmacokinetic gender differences. To assess the effect of coadministration of Pantoprazole on the bioavailability of BIBR 953 ZW.

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• AUCτ,ss (area under the plasma concentration time curve during a dosing interval at steady state)

  Day 4 and 7

• Cmax,ss (maximum measured concentration of the analyse in plasma at steady state over a uniform dosing interval τ)

  Day 4 and 7

• Aeτ,ss (amount of dose excreted in urine over one dosing interval at steady state)

  Day 4 and 7

• feτ,ss (percent of dose excreted in urine over one dosing interval at steady state)

  Day 4 and 7

• AUC0-tz,ss (area under the plasma concentration time curve (AUC) from zero time (pre dose) to the time of the last quantifiable concentration (tz))

  Day 4 and 7

• Cmin,ss (minimum measured concentration of the analyse in plasma at steady state over a uniform dosing interval τ)

  Day 4 and 7

• tmax,ss (time from last dosing to the maximum concentration of the analyse in plasma at steady state over a uniform dosing interval τ)

  Day 4 and 7

• t½,ss (terminal half-life, calculated from the terminal elimination rate constant)

  Day 4 and 7

Secondary Outcomes (7)

• CLR,ss (renal clearance at steady state following multiple dose administration)

  Day 4 and 7

• MRTss (steady state mean residence time)

  Day 4 and 7

• CL/F,ss (apparent clearance of the analyse in plasma at steady state after extravascular multiple dose administration)

  Day 4 and 7

• Vz/F,ss (apparent volume of distribution during the terminal phase at steady state following extravascular administration)

  Day 4 and 7

• Changes in activated partial thromboplastin time (aPTT)

  Day 4 and 7

Study Arms (2)

BIBR 1048 MS without Pantoprazole

EXPERIMENTAL

150 mg BIBR 1048 MS capsules administered twice daily over 6 days and once in the morning of the seventh day

Drug: BIBR 1048 MS

BIBR 1048 MS with Pantoprazole

EXPERIMENTAL

150 mg BIBR 1048 MS capsules administered twice daily over 6 days and once in the morning of the seventh day together with Pantoprazole. Pantoprazole administration (40 mg bid) started two days before administration og BIBR 1048 and ended in the morning of the seventh day.

Drug: BIBR 1048 MS; Drug: Pantoprazole

Interventions

BIBR 1048 MS DRUG

BIBR 1048 MS capsule 150 mg

BIBR 1048 MS with Pantoprazole; BIBR 1048 MS without Pantoprazole

Pantoprazole DRUG

Pantoprazole tablet 40 mg

BIBR 1048 MS with Pantoprazole

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Healthy male and female elderly subjects as determined by results of screening
• Signed written informed consent in accordance with GCP and local legislation
• Age ≥ 65, no upper limit
• BMI ≥ 18.5 and ≤ 29.9 kg/m2

You may not qualify if:

• Any finding at the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
• History of relevant 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)
• cranio-cerebral trauma
• Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
• Use of any drugs that 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

MeSH Terms

Interventions

Pantoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 25, 2014
• Study Start: November 1, 2002
• Primary Completion: February 1, 2003
• Last Updated: June 25, 2014

Record last verified: 2014-06