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HealthyPhase 1NCT02182349

Metabolism and Pharmacokinetics of Oral Solution of [14C]-BI 201335 in Healthy Male Volunteers

A Phase 1 study testing BI 201335 NA soft gelatin capsule and [14C]-BI 201335 NA radiolabelled drug 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 determine the pharmacokinetics (PK) of BI 201335 and total radioactivity including excretion mass balance, excretion pathways and metabolism following the oral administration of [14C]-BI 201335 at steady state. 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?
BI 201335 NA soft gelatin capsule and [14C]-BI 201335 NA radiolabelled drug
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
No sites listed yet
Study dates
Jun 2009to Jul 2009
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 males according to a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG (electrocardiogram), and clinical laboratory tests
  • Age 18 to 55 years, inclusive
  • Body mass index 18.5 to 29.9 kg/m2, inclusive
  • Nonsmoker
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

Who cannot join

  • Any finding in the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
  • Any evidence of a clinically relevant concomitant disease
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal, psychiatric or neurological disorders (including all forms of epilepsy)
  • Surgery of the gastrointestinal tract (except appendectomy)
  • History of relevant orthostatic hypotension, fainting spells or blackouts
  • Subjects with Gilbert's Syndrome
Show all 22Show fewer
  • Chronic or relevant acute infections
  • History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  • Intake of drugs with a long half-life (>24 hours) within one month prior to administration of the trial drug
  • Use of prescription medication, over-the-counter drugs or herbal preparations within 14 days prior to administration of the trial drug
  • Participation in another trial with an investigational drug within two months prior to administration of the trial drug or during the trial
  • History or evidence of habitual tobacco or nicotine use within six months prior to administration of the trial drug
  • Alcohol abuse (more than 2 ounces of alcohol/day)
  • Drug abuse in opinion of investigator
  • Blood donation (more than 100 mL within four weeks prior to administration of trial drug or during the trial)
  • Excessive physical activity within five days prior to administration of trial drug
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of trial centre
  • marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
  • Male subjects must agree to minimise the risk of female partners becoming pregnant from the dosing day until three months after the completion of the study. Acceptable methods of contraception for male volunteers include a vasectomy no less than three months prior to dosing, barrier contraception, or a medically accepted contraceptive method. For female partners of male volunteers, acceptable methods of contraception include intrauterine device, tubal ligation, hormonal contraceptive for at least two months, or diaphragm with spermicide
  • Participation in more than one other radiolabelled investigational drug trial within one year prior to administration of the trial drug. The previous radiolabelled trial drug must have been received more than six months prior to administration of the trial drug for this study, and the total exposure from this study and the previous study will be within the recommended levels considered safe (e.g., less than 5000 mrem whole body annual exposure)
  • Irregular defecation pattern (less than one bowel movement a day)

About this study

Official title: Metabolism and Pharmacokinetics of a Single Dose of 240 mg [14C]-BI 201335 Given as Oral Solution to Healthy Male Volunteers at Steady State of BI 201335 NA Maintained With Oral Capsules of 240 mg BI 201335, a Phase I, Single-arm, Open-label Trial

Study to determine the pharmacokinetics (PK) of BI 201335 and total radioactivity including excretion mass balance, excretion pathways and metabolism following the oral administration of [14C]-BI 201335 at steady state.

Conditions
Healthy
Being tested
BI 201335 NA soft gelatin capsule, [14C]-BI 201335 NA radiolabelled drug

What participants receive

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

  • BI 201335 NA soft gelatin capsuleDrug

  • [14C]-BI 201335 NA radiolabelled drugDrug

Study groups in NCT02182349
Study groupRoleWhat they receive
BI 201335 NAExperimentalmultiple doses of BI 201335 NA soft gelatin capsule on days 1-8 and 11-15 and one single dose of [14C]-BI 201335 NA radiolabelled drug on day 9
Receives: Drug: BI 201335 NA soft gelatin capsule; Drug: [14C]-BI 201335 NA radiolabelled drug

What is being measured

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

  1. Individual concentration-time profiles of [14C]-radioactivity in whole blood, plasma, saliva, urine, and faeces

    Measured: up to 28 days

  2. Individual concentration-time profiles of BI 201335 ZW in plasma and urine

    Measured: up to 28 days

  3. Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces

    Measured: up to 28 days

  4. Elucidation of metabolite structures and identification of major metabolites in urine, faeces, and plasma in comparison with various animal species

    Measured: up to 28 days

  5. Cblood cell/Cplasma ratio of [14C]-radioactivity

    Measured: up to 28 days

  6. Measurement of the plasma protein binding of total [14C]-radioactivity in human plasma samples ex vivo

    Measured: up to day 28

  7. Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)

    Measured: up to day 28

  8. tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)

    Measured: up to day 28

  9. Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)

    Measured: up to day 28

  10. AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)

    Measured: up to day 28

  11. λz,ss (terminal rate constant of the analyte in plasma at steady state)

    Measured: up to day 28

  12. t1/2,ss (terminal half-life of the analyte in plasma at steady state)

    Measured: up to day 28

  13. MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)

    Measured: up to day 28

  14. CL/F,ss (apparent clearance of the analyte in the plasma at steady state following multiple oral dose administration)

    Measured: up to day 28

  15. Vz/F,ss (apparent volume of distribution of the analyte during the terminal phase λz at steady state following oral administration)

    Measured: up to day 28

  16. Ae,urine,0-tz,ss (amount of analyte that is eliminated in urine at steady state from the time point 0 to time point tz)

    Measured: up to day 28

  17. fe,urine,t1-t2,ss (fraction of the analyte in % of dose that is eliminated in urine at steady state from the time point 0 to time point tz)

    Measured: up to day 28

  18. Ae,feces,t1-t2,ss (fraction of the analyte that is eliminated in faeces at steady state from time point 0 to time point tz)

    Measured: up to day 28

  19. fe,feces,0-tz,ss (fraction of the analyte eliminated in faeces at steady state from time point 0 to time point tz)

    Measured: up to day 28

  20. CLR,t1-t2,ss (renal clearance of the analyte at steady state from the time point 0 to time point tz)

    Measured: up to day 28

Secondary outcomes (6)

  1. Number of patients with abnormal findings in physical examination

    Measured: Baseline and day 28

  2. Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)

    Measured: Baseline, day 1, 10, 16 and 28

  3. Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)

    Measured: Baseline, day 1, 10, 16 and 28

  4. Number of patients with clinically significant changes in clinical laboratory tests (haematology, clinical chemistry, urinalysis)

    Measured: Baseline, day 10 and 28

  5. Number of patients with adverse events

    Measured: up to 28 days

  6. Assessment of tolerability on a 4-point scale by the investigator

    Measured: Day 28

Timeline

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

  1. First posted8 Jul 2014 (estimated)
  2. Study startJun 2009
  3. Primary completionJul 2009

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
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02182349
Sponsor's protocol ID
1220.33
Status last verified
Jul 2014
First submitted
2 Jul 2014
Last updated
18 Jul 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 201335 NA soft gelatin capsule and [14C]-BI 201335 NA radiolabelled drug 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 5 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 18 Jul 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?

Individual concentration-time profiles of [14C]-radioactivity in whole blood, plasma, saliva, urine, and faeces (time frame: up to 28 days). The study lists 20 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 NCT02182349.

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 18 Jul 2014.

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