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HealthyPhase 1NCT02211885

Excretion Balance of 14c-radiolabeled BIRB 796 BS in Normal Male Subjects

A Phase 1 study testing 14C-BIRB 796 BS 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 characterize the pharmacokinetics of 14C-radiolabeled BIRB 796 BS and its metabolites including excretion and mass balance of parent compound and radioactivity; to isolate, identify and quantify major radiolabeled metabolites of BIRB 796 in plasma, urine and feces 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?
14C-BIRB 796 BS
How many people
6 participants
Where
No sites listed yet
Study dates
Oct 2002to Nov 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 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male subjects as determined by results of screening. Health is confirmed by medical history, physical examination, laboratory testing and 12-lead electrocardiogram (ECG)
  • Signed written informed consent in accordance with Good Clinical Practice
  • Age ≥ 18 and ≤ 45 years
  • Subjects within 10% of the normal height: weight range defined by the Metropolitan Life Insurance Company Tables

Who cannot join

  • Any finding of the medical examination (including blood pressure, pulse rate, and ECG) deviating from normal and of clinical relevance
  • History of clinically significant disease including metabolic, endocrinologic, immunological, hepatic, renal, gastrointestinal, respiratory, cardiovascular, psychiatric or neurological
  • History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • Subjects with a history of drug abuse or alcoholism
  • Chronic or relevant acute (within 1 month of screening) infections
  • Subjects who have taken prescription within one month or over-the-counter drugs within two weeks of the start of the trial
Show all 12Show fewer
  • Participation in another trial with an investigational drug (≤ 2 months prior to administration or during trial)
  • Inability to refrain from smoking on trial days
  • Blood donation > 400 mL (within 1 month prior to administration or during the trial)
  • Any laboratory value outside 10% of the reference range of clinical relevance (but not exclusive to) total white cell count ≥ 10 x 10**9/L, any hemoglobin < 12 mg/dl or >15 mg/dl. Protein on urine dipstick
  • Positive urine drug screen, positive HIV or Hepatitis C antibodies
  • History of any familial bleeding disorder

About this study

Official title: A Phase I Single Oral Dose (100 mg) Trial to Characterize the Excretion Balance of 14c-radiolabeled BIRB 796 BS and to Determine Its Metabolites in Normal Male Subjects

Study to characterize the pharmacokinetics of 14C-radiolabeled BIRB 796 BS and its metabolites including excretion and mass balance of parent compound and radioactivity; to isolate, identify and quantify major radiolabeled metabolites of BIRB 796 in plasma, urine and feces

Conditions
Healthy
Being tested
14C-BIRB 796 BS

What participants receive

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

  • 14C-BIRB 796 BSDrug

    14C-radiolabeled BIRB 796 BS

What is being measured

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

  1. Cumulative amount of 14C-BIRB 796 BS radioactivity excreted in feces (percent of dose)

    Measured: up to 5 days

  2. Cumulative amount of 14C-BIRB 796 BS radioactivity excreted in urine (percent of dose)

    Measured: up to 5 days

  3. Maximum observed Concentration (Cmax) of 14C-BIRB 796BS in plasma

    Measured: up to 96 hours after drug administration

  4. Area under the Concentration versus time curve from time 0 to infinity (AUC0-∞) of 14C-BIRB 796BS in plasma

    Measured: up to 96 hours after drug administration

  5. Time To The Maximum Concentration (tmax) of 14C-BIRB 796BS in plasma

    Measured: up to 96 hours after drug administration

  6. Elimination Half-Life (t1/2) of 14C-BIRB 796BS in plasma

    Measured: up to 96 hours after drug administration

  7. Erythrocyte-plasma partition ratio of 14C-radioactivity

    Measured: up to 5 days

  8. Cmax of 14C-BIRB 796BS in blood

    Measured: up to 96 hours after drug administration

  9. AUC0-∞ of 14C-BIRB 796BS in blood

    Measured: up to 96 hours after drug administration

  10. tmax of 14C-BIRB 796BS in blood

    Measured: up to 96 hours after drug administration

  11. t1/2 of 14C-BIRB 796BS in blood

    Measured: up to 96 hours after drug administration

  12. Cmax of BIRB 796BS in plasma

    Measured: up to 96 hours after drug administration

  13. AUC0-∞ of BIRB 796BS in plasma

    Measured: up to 96 hours after drug administration

  14. tmax of BIRB 796BS in plasma

    Measured: up to 96 hours after drug administration

  15. t1/2 of BIRB 796BS in plasma

    Measured: up to 96 hours after drug administration

  16. Quantification of radiolabeled metabolites in urine (percent of dose)

    Measured: up to 5 days

  17. Quantification of radiolabeled metabolites in feces (percent of dose)

    Measured: up to 5 days

  18. Quantification of radiolabeled metabolites in plasma (percent of dose)

    Measured: up to 96 hours after drug administration

Secondary outcomes (2)

  1. Excretion of 14C-radioactivity in saliva (percent of dose)

    Measured: up to 24 hours after drug administration

  2. Excretion of 14C-radioactivity in expired air (percent of dose)

    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 posted8 Aug 2014 (estimated)
  2. Study startOct 2002
  3. Primary completionNov 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02211885
Sponsor's protocol ID
1175.6
Status last verified
Aug 2014
First submitted
7 Aug 2014
Last updated
8 Aug 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 14C-BIRB 796 BS 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 12 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 8 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. 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?

Cumulative amount of 14C-BIRB 796 BS radioactivity excreted in feces (percent of dose) (time frame: up to 5 days). The study lists 18 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 NCT02211885.

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 8 Aug 2014.

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