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CompletedNCT02258971Updated Oct 8, 2014

Metabolism and Pharmacokinetics of [14C] BEA 2180 BR Administered Orally Compared to [14C] BEA 2180 BR Administered Intravenously in Healthy Male Volunteers

A Phase 1 interventional study of BEA 2180 BR oral and BEA 2180 BR infusion in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 35 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-08.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Non-randomized
Ages
35 Years to 70 Years
Sex
Male
01

Study summary

Primary objectives: To determine the basic pharmacokinetics of BEA 2180 BR, its metabolites CD 1975 ZW and CD 1976 ZW and radioactivity including excretion mass balance, excretion pathways and metabolism following the oral and intravenous administration of [14C] BEA 2180 BR

Secondary objectives: To determine safety and tolerability following single dose oral and iv administration of BEA 2180 BR in healthy male volunteers.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  1. Healthy males according to the following criteria:

    Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead electrocardiogram (ECG), clinical laboratory tests

  2. Age ≥35 and Age ≤70 years
  3. BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
  4. Subjects must agree to minimize the risk of female partners becoming pregnant from the dosing day until 3 months after the completion of the study. Acceptable methods of contraception for male volunteers include a vasectomy no less than 3 months prior to dosing, barrier contraception or a medically accepted contraceptive method. For female partners of male volunteers, acceptable methods of contraception include intra-uterine device, tubal ligation, hormonal contraceptive since at least two months and diaphragm with spermicide
  5. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

  1. Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and ECG) deviating from normal and of clinical relevance
  2. Any evidence of a clinically relevant concomitant disease
  3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  5. History of relevant orthostatic hypotension, fainting spells or blackouts
  6. Chronic or relevant acute infections
  7. History of relevant allergy/hypersensitivity (including allergy to study drug or its excipients)
  8. Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
  9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
  10. Participation in another trial with an investigational drug within two months prior to administration or during the trial
  11. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
  12. Inability to refrain from smoking during the stay in the trial centre
  13. Alcohol abuse (more than 2 units of alcoholic beverages per day or more than 14 units per week (1 unit equals 1 pint [285 mL] of beer or lager, 1 glass [125 mL] of wine, 25 mL shot of 40% spirit)more than 60 g/day).
  14. Drug abuse
  15. Blood donation (more than 100 mL within 60 days prior to study drug administration or during the trial)
  16. Excessive physical activities (within one week prior to administration or during the trial until follow-up examination)
  17. Any laboratory value outside the reference range that is of clinical relevance
  18. Inability to comply with dietary regimen of study centre

  19. A marked baseline prolongation of QT/Heart rate-corrected QT interval (QTc) interval (e.g., repeated demonstration of a QTc interval >450 ms)

    Exclusion criteria specific for this study:

  20. Veins unsuitable for infusion and blood sampling
  21. Pulse rate (PR) interval >220 ms or QRS interval >120 ms
  22. Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)), during work or during participation in a medical trial in the previous year
  23. Irregular defecation pattern (less than once per 2 days)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    BEA 2180 BR oral

    Drug: BEA 2180 BR oral

  • Active comparator
    BEA 2180 BR infusion

    Drug: BEA 2180 BR infusion

Interventions

  • DrugBEA 2180 BR oral

    Oral solution

  • DrugBEA 2180 BR infusion

    Solution for infusion to be reconstituted with isotonic saline

06

What researchers measure

Primary outcomes

  1. Individual time course profiles of [14C] radioactivity

    Time frame: Up to 312 hours after drug administration

  2. Individual time course profiles of BEA 2180 and its metabolites CD 1975 ZW and CD 1976 ZW

    Time frame: Up to 312 hours after drug administration

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

    Time frame: Up to 312 hours after drug administration

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

    Time frame: Up to 312 hours after drug administration

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

    Time frame: Up to 96 hours after drug administration

  6. Cmax (maximum concentration of the analyte(s) in plasma)

    Time frame: Up to 96 hours after drug administration

  7. tmax (time from dosing to the maximum concentration of the analyte(s) in plasma)

    Time frame: Up to 96 hours after drug administration

  8. AUC0-tz (area under the concentration-time curve of the analyte(s) in plasma over the time interval from 0 to the time of the last quantifiable data point)

    Time frame: Up to 96 hours after drug administration

  9. AUC0-∞ (area under the concentration-time curve of the analyte(s) in plasma over the time interval from 0 to infinity)

    Time frame: Up to 96 hours after drug administration

  10. λz (terminal rate constant in plasma)

    Time frame: Up to 96 hours after drug administration

  11. t1/2 (terminal half-life of the analyte(s) in plasma)

    Time frame: Up to 96 hours after drug administration

  12. MRT (mean residence time of the analyte(s) in the body)

    Time frame: Up to 96 hours after drug administration

  13. CL (total clearance of the analyte in plasma)

    Time frame: Up to 96 hours after drug administration

  14. Vz (apparent volume of distribution during the terminal phase λz)

    Time frame: Up to 96 hours after drug administration

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

    Time frame: Up to 96 hours after drug administration

  16. fe0-tz (amount of analyte excreted in urine within the time interval zero to tz in % of dose)

    Time frame: Up to 312 hours after drug administration

  17. fefaeces,0-tz (amount of analyte excreted in faeces within the time interval zero to tz in %) of dose, additionally excretion within each sampling interval will be calculated)

    Time frame: Up to 312 hours after drug administration

  18. CLR,0-tz (renal clearance of analyte)

    Time frame: Up to 96 hours after drug administration

  19. Fa (fraction of drug absorbed after oral administration based on radioactivity data) based on oral and i.v. data

    Time frame: Up to 96 hours after drug administration

Secondary outcomes

  1. Number of participants with abnormal findings in physical examination

    Time frame: Up to day 29 after first drug administration

  2. Number of participants with clinically significant changes in vital signs

    Time frame: Up to day 29 after first drug administration

  3. Number of participants with abnormal findings in 12-lead ECG

    Time frame: Up to day 29 after first drug administration

  4. Number of participants with abnormal changes in clinical laboratory parameters

    Time frame: Up to day 29 after first drug administration

  5. Number of participants with adverse events

    Time frame: Up to day 29 after first drug administration

  6. Investigator global clinical assessment on a 4-point scale

    Time frame: Up to day 15 after first drug administration

  7. Investigator assessed local tolerability on a 6-point scale

    Time frame: Up to day 15 after first drug administration

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02258971
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 8, 2014
Start date
Mar 2007
Primary completion
May 2007
Last update
Oct 8, 2014
View the source record on ClinicalTrials.gov ↗

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