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HealthyPhase 1NCT02170636

Bioavailability of BIBR 953 ZW After Oral Administration of BIBR 1048 MS in Healthy Subjects

A Phase 1 study testing BIBR 1048 MS Capsule E, BIBR 1048 MS Capsule F and BIBR 1048 MS Capsule G in people with Healthy, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study to assess the amount of BIBR 953 ZW in urine after administration of 50 mg BIBR 1048 bid over three days each administered as four experimental formulations relative to drinking solution with and without coadministration of 40 mg Pantoprazole Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
BIBR 1048 MS Capsule E, BIBR 1048 MS Capsule F and BIBR 1048 MS Capsule G
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
Jan 2002to Mar 2002
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male subjects as determined by results of screening
  • Signed written informed consent in accordance with GCP and local legislation
  • Age ≥ 18 and ≤ 55 years
  • Broca ≥ 18.5 and ≤ 29.9 kg/m2

Who cannot join

  • 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, 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
Show all 22Show fewer
  • 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
  • Alcohol abuse (> 60 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 < 150000/µl

About this study

Official title: Bioavailability of BIBR 953 ZW After 50 mg of BIBR 1048 MS (Oral Prodrug of BIBR 953) in 4 Experimental Formulations Relative to Drinking Solution of BIBR 1048 MS, Each Treatment Given Bid Over 3 Days, in Healthy Subjects. Intraindividual Comparison (5-way Crossover), Randomised, Open. For Each of the 5 Treatments, Investigation of 2 Conditions: With and Without Pantoprazole (Intraindividual, Open Comparison).

Study to assess the amount of BIBR 953 ZW in urine after administration of 50 mg BIBR 1048 bid over three days each administered as four experimental formulations relative to drinking solution with and without coadministration of 40 mg Pantoprazole

Conditions
Healthy
Being tested
BIBR 1048 MS Capsule E, BIBR 1048 MS Capsule F, BIBR 1048 MS Capsule G, BIBR 1048 MS Tablet H, BIBR 1048 MS Drinking solution

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIBR 1048 MS Capsule EDrug

    50 mg BIBR 1048 MS

  • BIBR 1048 MS Capsule FDrug

    50 mg BIBR 1048 MS

  • BIBR 1048 MS Capsule GDrug

    50 mg BIBR 1048 MS

  • BIBR 1048 MS Tablet HDrug

    50 mg BIBR 1048 MS

  • BIBR 1048 MS Drinking solutionDrug

    50 mg BIBR 1048 MS tartaric acid solution

  • PantoprazoleDrug

    40 mg Pantoprazole

Study groups in NCT02170636
Study groupRoleWhat they receive
Period 1: BIBR 1048 MS + PantoprazoleExperimentalFive treatments with oral administration of 50 mg BIBR 1048 MS (bid for 3 days) and 40 mg Pantoprazole (bid). Randomised sequence. BIBR 1048 MS Capsule E with pantoprazole; BIBR 1048 MS Capsule F with pantoprazole; BIBR 1048 MS Capsule G with pantoprazole; BIBR 1048 MS Tablet H with pantoprazole; BIBR 1048 MS Drinking solution with pantoprazole
Receives: Drug: BIBR 1048 MS Capsule E; Drug: BIBR 1048 MS Capsule F; Drug: BIBR 1048 MS Capsule G; Drug: BIBR 1048 MS Tablet H; Drug: BIBR 1048 MS Drinking solution; Drug: Pantoprazole
Period 2: BIBR 1048 MSExperimentalThree treatments (fixed sequence) with oral administration of 50 mg BIBR 1048 MS (bid for 3 days). 1. BIBR 1048 MS Capsule E without pantoprazole; 2. BIBR 1048 MS Tablet H without pantoprazole; 3. BIBR 1048 MS Drinking solution without pantoprazole
Receives: Drug: BIBR 1048 MS Capsule E; Drug: BIBR 1048 MS Tablet H; Drug: BIBR 1048 MS Drinking solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total amount of BIBR 953 ZW excreted into urine over one dose interval (Ae0-12)

    Measured: Day 1 to 16 of each treatment period

  2. AUCss (area under the plasma concentration-time curve at steady state) of BIBR 953 ZW

    Measured: 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after administration of study drug on day 3 of second treatment period

Secondary outcomes (2)

  1. Cmax,ss (maximum concentration at steady state) of BIBR 953 ZW

    Measured: 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after administration of study drug on day 3 of second treatment period

  2. tmax,ss (time from dosing to Cmax at steady state) of BIBR 953 ZW

    Measured: 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after administration of study drug on day 3 of second treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2014 (estimated)
  2. Study startJan 2002
  3. Primary completionMar 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02170636
Sponsor's protocol ID
1160.32
Status last verified
Jun 2014
First submitted
20 Jun 2014
Last updated
23 Jun 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIBR 1048 MS Capsule E, BIBR 1048 MS Capsule F and BIBR 1048 MS Capsule G in people with Healthy, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total amount of BIBR 953 ZW excreted into urine over one dose interval (Ae0-12) (time frame: Day 1 to 16 of each treatment period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02170636.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2014.

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