BIBR 953 ZW in Healthy Elderly Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BIBR 1048 MS; Drug: Pantoprazole

• Registration Number: NCT02173730
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2003-02
• Status Verified: 2014-06
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-24
• Last Update Submitted: 2014-06-24
• Study First Posted: 2014-06-25
• Last Update Posted: 2014-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• 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

Read More

Exclusion Criteria

• 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

• Alcohol intake (>30 - 40 g/day)

• Drug abuse

• Blood donation within 1 month prior to administration or during the trial

• Excessive physical activities within 5 days prior to administration or during the trial

• Any laboratory value outside the clinically accepted reference range

• History of any familial bleeding disorder

• Thrombocytes < 140000/μl (male) or < 156000/μl (female)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIBR 1048 MS without Pantoprazole	BIBR 1048 MS	150 mg BIBR 1048 MS capsules administered twice daily over 6 days and once in the morning of the seventh day
BIBR 1048 MS with Pantoprazole	BIBR 1048 MS	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.
BIBR 1048 MS with Pantoprazole	Pantoprazole	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Changes in ecarin clotting time (ECT)	Day 4 and 7
Occurrence of Adverse Events	up to 10 days