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HealthyPhase 1NCT02209805

Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered to Healthy Human Subjects

A Phase 1 study testing BIRB 796 BS, low dose and BIRB 796 BS, high dose 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 safety and pharmacokinetics of BIRB 796 BS tablets administered as multiple daily doses at various dose levels. 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?
BIRB 796 BS, low dose and BIRB 796 BS, high dose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
49 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 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 and local legislation
  • Age >= 18 and <= 45 years
  • Broca >= - 20 % and <= + 20%
  • Able to communicate well with the investigator and to comply with study requirements
  • > 10 elimination half lives present since last use of any investigational drug for that investigational drug
  • Laboratory values within a clinically relevant reference range

Who cannot join

  • Any finding of the medical examination (including blood pressure, pulse rate, temperature, and EKG) 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 23Show fewer
  • History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • History of vasculitis (past history of fever, malaise, myalgias, rash, etc.)
  • 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 (< 1 months prior to administration or during trial)
  • Smoker
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (> 60 g/day)
  • Drug abuse
  • Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.) < one week prior to administration of study drug
  • Blood donation or loss > 400 mL (< 1 month prior to administration or during the trial)
  • Excessive physical activities (< 5 days prior to administration or during the trial)
  • Following specific laboratory findings: total white blood cell >= 10 x 109/L, C-Reactive Protein >= 4.5 mg/L, gamma-glutamyl-transferase >= 25 U/L, aspartate transaminase >= 16 U/L, alanine transaminase >= 20 U/L any erythrocytes or > 15 mg/dl protein on urine dipstick
  • Any EKG value outside of the reference range of clinical relevance including, but not limited to QTcB > 480 ms, PR interval > 240 ms, QRS interval > 110 ms
  • History of any familial bleeding disorder
  • Inability to comply with dietary regimen of study centre
  • Inability to comply with investigator's instructions

About this study

Official title: Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered Twice Daily Orally (Total Daily Dose 30, 60, and 120 mg) to Healthy Human Subjects for 14 Days. A Double-blind, Placebo-controlled, Parallel Group Study.

Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as multiple daily doses at various dose levels.

Conditions
Healthy
Being tested
BIRB 796 BS, low dose, BIRB 796 BS, high dose, Placebo

What participants receive

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

  • BIRB 796 BS, low doseDrug

  • BIRB 796 BS, high doseDrug

  • PlaceboDrug

Study groups in NCT02209805
Study groupRoleWhat they receive
BIRB 796 BS, low doseExperimentalNot described
Receives: Drug: BIRB 796 BS, low dose
BIRB 796 BS, high doseExperimentalNot described
Receives: Drug: BIRB 796 BS, high dose
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
BIRB 796 BS, medium doseExperimentalNot described
Receives: Drug: BIRB 796 BS, low dose; Drug: BIRB 796 BS, high dose

What is being measured

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

  1. Number of patients with clinically significant changes in vital signs

    Measured: up to 21 days

  2. Number of patients with clinically significant changes in laboratory parameters

    Measured: up to 21 days

  3. Number of patients with abnormal findings in electrocardiogram

    Measured: up to 21 days

  4. Number of patients with adverse events

    Measured: up to 24 days

Secondary outcomes (8)

  1. Maximum concentration of the analyte in plasma (Cmax) for several time points

    Measured: up to 36 hours after dosing

  2. Area under the plasma concentration versus time curve (AUC) for several time points

    Measured: up to 36 hours after dosing

  3. Time at which maximum plasma concentration occurred over a dosing interval (tmax)

    Measured: up to 36 hours after dosing

  4. Terminal elimination rate constant (λZ)

    Measured: up to 36 hours after dosing

  5. Elimination half-life (t1/2)

    Measured: up to 36 hours after dosing

  6. Mean residence time (MRT)

    Measured: up to 36 hours after dosing

  7. Apparent oral clearance (CL/F)

    Measured: up to 36 hours after dosing

  8. Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F)

    Measured: up to 36 hours after dosing

Timeline

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

  1. First posted6 Aug 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
Parallel groups
Masking
Double blind
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02209805
Sponsor's protocol ID
1175.14
Status last verified
Aug 2014
First submitted
5 Aug 2014
Last updated
6 Aug 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIRB 796 BS, low dose and BIRB 796 BS, high dose 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 7 inclusion and 23 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 6 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 patients with clinically significant changes in vital signs (time frame: up to 21 days). 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 NCT02209805.

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 6 Aug 2014.

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