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HealthyPhase 1NCT02170584

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

A Phase 1 study testing BIBR 953 ZW IV, BIBR 1048 MS tablet and BIBR 1048 MS oral solution 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

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… Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
BIBR 953 ZW IV, BIBR 1048 MS tablet and BIBR 1048 MS oral solution
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
No sites listed yet
Study dates
Jan 2001to Mar 2001
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 50 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 ≤ 50 years
  • Broca ≥ - 20% and ≤ + 20%

Who cannot join

  • 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
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 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: Tolerability of Single Rising Doses of 0.1 mg, 1 mg, and 5 mg BIBR 953 ZW IV (Placebo-controlled in Each Dose Group; Substudy 1) and Absolute and Relative Bioavailability of 100mg BIBR 1048 Tablet and of Solution and of 1 mg or 5 mg BIBR 953 ZW IV (Randomized, Three-way Crossover; Substudy 2).

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
Being tested
BIBR 953 ZW IV, BIBR 1048 MS tablet, BIBR 1048 MS oral solution, BIBR 953 ZW IV Placebo

What participants receive

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

  • BIBR 953 ZW IVDrug

  • BIBR 1048 MS tabletDrug

  • BIBR 1048 MS oral solutionDrug

  • BIBR 953 ZW IV PlaceboDrug

Study groups in NCT02170584
Study groupRoleWhat they receive
BIBR 953 ZW IVExperimentalNot described
Receives: Drug: BIBR 953 ZW IV
BIBR 1048 MS oral solutionActive comparatorNot described
Receives: Drug: BIBR 1048 MS oral solution
BIBR 1048 MS tabletExperimentalNot described
Receives: Drug: BIBR 1048 MS tablet
BIBR 953 ZW IV PlaceboPlacebo comparatorNot described
Receives: Drug: BIBR 953 ZW IV Placebo

What is being measured

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

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

    Measured: up to 48 hours after drug administration

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

    Measured: up to 48 hours after drug administration

  3. Cmax (Maximum plasma concentration after oral administration)

    Measured: up to 48 hours after drug administration

  4. Cumulative urinary excretion of BIBR 953 ZW administered intravenously

    Measured: up to 48 hours after drug administration

Secondary outcomes (18)

  1. changes in activated partial thromboplastin time (aPTT )

    Measured: up to 48 hours after drug administration

  2. changes in prothrombin time (PT)

    Measured: up to 48 hours after drug administration

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

    Measured: 29 minutes after start of infusion

  4. t1/2 (terminal half-life)

    Measured: up to 48 hours after infusion

  5. CLtot (total clearance of drug from plasma)

    Measured: up to 48 hours after infusion

  6. CLren (renal clearance from plasma)

    Measured: up to 48 hours after infusion

  7. MRTdisp (Mean time of residence of drug molecules in the body after intravascular administration)

    Measured: up to 48 hours after infusion

  8. Vss (apparent volume of distribution at steady state)

    Measured: up to 48 hours after infusion

  9. Vz (Apparent volume of distribution during the terminal elimination phase)

    Measured: up to 48 hours after infusion

  10. MRTtot (total mean residence time)

    Measured: up to 48 hours after oral administration

  11. CLtot/F (total clearance after oral administration)

    Measured: up to 48 hours after oral administration

  12. tmax (time to reach the peak plasma concentration)

    Measured: up to 48 hours after oral administration

  13. Vz/F (apparent volume of distribution of the terminal elimination phase after oral administration)

    Measured: up to 48 hours after oral administration

  14. changes in Ecarin clotting time (ECT)

    Measured: up to 48 hours after drug administration

  15. changes in thrombin time (TT)

    Measured: up to 48 hours after drug administration

  16. changes in vital signs (systolic and diastolic blood pressure, pulse rate)

    Measured: up to 1 month

  17. changes in electrocardiogram

    Measured: up to 1 month

  18. occurrence of adverse events

    Measured: up to 1 month

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 2001
  3. Primary completionMar 2001

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
Double blind
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02170584
Sponsor's protocol ID
1160.5
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 953 ZW IV, BIBR 1048 MS tablet and BIBR 1048 MS oral solution 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. Some participants in this study may receive a placebo. 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?

AUC0-inf (Area under the plasma concentration-time curve extrapolated to infinity) (time frame: up to 48 hours after drug administration). The study lists 4 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 NCT02170584.

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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