AzTrials
AzTrials

HealthyPhase 1NCT02208856

Safety, Pharmacokinetics and Pharmacodynamics of Single Rising Doses Oral BIRB 796 BS in Healthy Human Subjects

A Phase 1 study testing BIBR 796 BS and high fat standardized breakfast 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
Search all trials

Trial summary

To assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating single doses, with and without a 64 g fat breakfast at one selected dose. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
BIBR 796 BS and high fat standardized breakfast
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
No sites listed yet
Study dates
Sep 1999to Dec 1999
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 45 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 good clinical practice (GCP) and local legislation
  • Age >= 18 and <= 45 years
  • Broca >= -20% and <= +20%

Who cannot join

  • Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of gastrointestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • History of orthostatic hypotension, fainting spells or blackouts
  • Chronic or relevant acute infections
Show all 18Show fewer
  • History of allergy/hypersensitivity (including drug allergy) which is deemed relevant ot the trial as judged by the investigator
  • Intake of drugs with a long half-life (> 24 hours) (= 1 month prior to administration or during the trial)
  • Use of any drugs, which might influence the results of the trial (= 10 days prior to administration or during the trial)
  • Participation in another trial with an investigational drug (=2 months prior to administration or during trial)
  • Smoker (> 10 cigarettes of > 3 cigars of > 3 pipes/day)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (> 60 g/day)
  • Drug abuse
  • Blood donation > 400 ml (=1 month prior to administration of during the trial)
  • Excessive physical activities (= 5 days prior to administration or during the trial)
  • Any laboratory value outside the reference range of clinical relevance (but not exclusive to) total white cell count >= 10 x 10**9/L, C-reactive protein >= 4.5 mg/L, any haemoglobin or > 15 mg/dl protein on urine dipstick
  • History of any familial bleeding disorder

About this study

Official title: Safety, Pharmacokinetics and Pharmacodynamics of Single Rising Doses (1, 4, 15, 50, 100, 200, 400, and 600 mg) Oral BIRB 796 BS in Healthy Human Subjects. A Placebo Controlled, Randomised Study, Double Blinded at Each Dose Level

To assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating single doses, with and without a 64 g fat breakfast at one selected dose.

Conditions
Healthy
Being tested
BIBR 796 BS, Placebo, high fat standardized breakfast

What participants receive

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

  • BIBR 796 BSDrug

  • PlaceboDrug

  • high fat standardized breakfastOther

Study groups in NCT02208856
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
BIBR 796 BS food effectExperimentalNot described
Receives: Drug: BIBR 796 BS; Other: high fat standardized breakfast
BIBR 796 BSExperimentalNot described
Receives: Drug: BIBR 796 BS

What is being measured

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

  1. Number of subjects with clinically relevant changes in vital signs

    Measured: Baseline, up to 96 hours after drug administration

  2. Number of subjects with clinically relevant changes in laboratory measurements

    Measured: Baseline, up to 96 hours after drug administration

  3. Number of subjects with clinically relevant changes in electrocardiograms (ECG)

    Measured: Baseline, up to 96 hours after drug administration

  4. Number of subjects with adverse events

    Measured: up to 96 hours after drug administration

Secondary outcomes (11)

  1. Maximum concentration of the analyte in plasma (Cmax)

    Measured: up to 48 hours after drug administration

  2. Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC0-inf)

    Measured: up to 48 hours after drug administration

  3. Time from dosing to the maximum concentration of the analyte in plasma (Tmax)

    Measured: up to 48 hours after drug administration

  4. Terminal rate constant of the analyte in plasma (λz)

    Measured: up to 48 hours after drug administration

  5. Half life of the analyte in plasma (t1/2)

    Measured: up to 48 hours after drug administration

  6. Mean residence time of the analyte in the body (MRTtot)

    Measured: up to 48 hours after drug administration

  7. Apparent clearance of the analyte in plasma (CL/F)

    Measured: up to 96 hours after drug administration

  8. Apparent volume of distribution during the terminal phase λz (Vz/F)

    Measured: up to 48 hours after drug administration

  9. Mac-1/L selectin ratio of formyl-methionyl-leucyl-phenylalanine (fMLP)-stimulated to unstimulated neutrophils

    Measured: up to 48 hours after drug administration

  10. Mac-1/L selectin ratio of TNFalpha-stimulated to unstimulated neutrophils

    Measured: up to 48 hours after drug administration

  11. Percent changes in TNFalpha production

    after ex vivo stimulation of whole blood with endotoxin

    Measured: up to 48 hours after drug administration

Timeline

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

  1. First posted5 Aug 2014 (estimated)
  2. Study startSep 1999
  3. Primary completionDec 1999

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
Parallel groups
Masking
Double blind
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02208856
Sponsor's protocol ID
1175.1
Status last verified
Aug 2014
First submitted
4 Aug 2014
Last updated
5 Aug 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIBR 796 BS and high fat standardized breakfast 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 18 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 5 Aug 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?

Number of subjects with clinically relevant changes in vital signs (time frame: Baseline, up to 96 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 NCT02208856.

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 5 Aug 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in