NCT02170896

Brief Summary

To assess the amount of BIBR 953 ZW in urine of 50 mg of BIBR 1048 bid over three days each administered as four experimental capsule formulations relative to drinking solution with and without coadministration of 40 mg pantoprazole.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
12.6 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
Last Updated

June 23, 2014

Status Verified

June 1, 2014

Enrollment Period

2 months

First QC Date

June 20, 2014

Last Update Submit

June 20, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Ae 0-12h: amount of drug (total BIBR 953 ZW) excreted into urine during all individual dosing intervals

    up to 3 days after each administration

  • Area under the concentration time course at steady state (AUCss)

    0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours after study drug administration on day 3 of period 2

Secondary Outcomes (3)

  • Occurence of adverse events

    up to 40 days

  • Maximum plasma concentration at steady state (Cmax,ss)

    0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours after study drug administration on day 3 of period 2

  • Time at which maximum plasma concentration occurs after dosing during steady state (tmax,ss)

    0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours after study drug administration on day 3 of period 2

Study Arms (8)

Period 1: BIBR1048 MS Capsule A+Pantoprazole

EXPERIMENTAL
Drug: BIBR 1048 MS Capsule ADrug: Pantoprazole

Period 1: BIBR1048 MS Capsule B+Pantoprazole

EXPERIMENTAL
Drug: BIBR 1048 MS Capsule BDrug: Pantoprazole

Period 1: BIBR1048 MS Capsule C+Pantoprazole

EXPERIMENTAL
Drug: BIBR 1048 MS Capsule CDrug: Pantoprazole

Period 1: BIBR1048 MS Capsule D+Pantoprazole

EXPERIMENTAL
Drug: BIBR 1048 MS Capsule DDrug: Pantoprazole

Period 1: BIBR1048 MS solution+Pantoprazole

ACTIVE COMPARATOR
Drug: BIBR 1048 MS tartaric acid solutionDrug: Pantoprazole

Period 2: BIBR1048 MS Capsule C

EXPERIMENTAL
Drug: BIBR 1048 MS Capsule C

Period 2: BIBR1048 MS Capsule D

EXPERIMENTAL
Drug: BIBR 1048 MS Capsule D

Period 2: BIBR1048 MS solution

ACTIVE COMPARATOR
Drug: BIBR 1048 MS tartaric acid solution

Interventions

BIBR 1048 MS Capsule ADRUG
Period 1: BIBR1048 MS Capsule A+Pantoprazole
BIBR 1048 MS Capsule BDRUG
Period 1: BIBR1048 MS Capsule B+Pantoprazole
BIBR 1048 MS Capsule CDRUG
Period 1: BIBR1048 MS Capsule C+PantoprazolePeriod 2: BIBR1048 MS Capsule C
BIBR 1048 MS Capsule DDRUG
Period 1: BIBR1048 MS Capsule D+PantoprazolePeriod 2: BIBR1048 MS Capsule D
BIBR 1048 MS tartaric acid solutionDRUG
Period 1: BIBR1048 MS solution+PantoprazolePeriod 2: BIBR1048 MS solution
PantoprazoleDRUG
Period 1: BIBR1048 MS Capsule A+PantoprazolePeriod 1: BIBR1048 MS Capsule B+PantoprazolePeriod 1: BIBR1048 MS Capsule C+PantoprazolePeriod 1: BIBR1048 MS Capsule D+PantoprazolePeriod 1: BIBR1048 MS solution+Pantoprazole

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects as determined by results of screening
  • Signed written informed consent in accordance with GCP (Good Clinical Practice) and local legislation
  • Age \>= 18 and \<= 55 years
  • Body Mass Index (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 (electrocardiogram)) deviation from normal and of clinical relevance
  • History of or current 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
  • History of any bleeding disorder including prolonged or habitual bleeding
  • History of other hematologic disease
  • History of cerebral bleeding (e.g. after a car accident)
  • History of commotio cerebri
  • Intake of drug 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 abuse (\> 60g/day)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Fumigant 93Pantoprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
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

October 1, 2001

Primary Completion

December 1, 2001

Last Updated

June 23, 2014

Record last verified: 2014-06