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CompletedNCT02214953Updated Aug 13, 2014

Bioavailability of Four Oral Prototype Extended Release Formulations With BI 11634 in Healthy Male Volunteers

A Phase 1 interventional study of BI 11634 ER formulation A and BI 11634 ER formulation B in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-13.

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

Phase
Phase 1
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
21 Years to 45 Years
Sex
Male
01

Study summary

To compare the oral bioavailability and rate of absorption of four prototype extended-release (ER) formulations with BI 11634 (single doses) to immediate-release (IR) tablets 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
21 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy Caucasian males according to the following criteria, based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, clinical laboratory tests
  • Age ≥21 and ≤45 years
  • Haemoglobin within the normal ranges.
  • Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
  • 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

Exclusion Criteria:

  • Relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Relevant surgery of gastrointestinal tract
  • History of any bleeding disorder or acute blood coagulation defect, for the subject itself or any person of his family as far as known
  • History of gastric ulcera and cholecystectomy
  • Occult blood in faeces
  • Relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • History of relevant orthostatic hypotension, fainting spells or blackouts
  • Relevant chronic or acute infections
  • History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • 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
  • 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
  • Use of acetylsalicylic acid or any other non-steroidal anti-inflammatory drugs (NSAID) within 2 weeks of study start until the end of study
  • Participation in another trial with an investigational drug within two months prior to administration or during the trial
  • Alcohol abuse (more than 40 g/day)
  • Drug abuse
  • Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  • Excessive physical activities (within one week prior to administration or during the trial)
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to understand and comply with protocol requirements, instructions and protocol stated restrictions, the nature, scope and possible consequences of the study
  • Subjects with a history within the past six weeks of closed-head or torso trauma or deceleration injury such as an automobile accident or fall from a significant height
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    BI 11634 ER formulation A

    Drug: BI 11634 ER formulation A

  • Experimental
    BI 11634 ER formulation B

    Drug: BI 11634 ER formulation B

  • Experimental
    BI 11634 ER formulation M

    Drug: BI 11634 ER formulation M

  • Experimental
    BI 11634 ER formulation C

    Drug: BI 11634 ER formulation C

  • Active comparator
    BI 11634 IR tablet

    Drug: BI 11634 IR tablet

Interventions

  • DrugBI 11634 ER formulation A
  • DrugBI 11634 ER formulation B
  • DrugBI 11634 ER formulation M
  • DrugBI 11634 ER formulation C
  • DrugBI 11634 IR tablet
06

What researchers measure

Primary outcomes

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

    Time frame: up to 48 hours after drug administraton

  2. Cmax (maximum measured concentration of analyte in plasma)

    Time frame: up to 48 hours after drug administraton

Secondary outcomes

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

    Time frame: up to 48 hours after drug administration

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

    Time frame: up to 48 hours after drug administration

  3. λz (terminal rate constant in plasma)

    Time frame: up to 48 hours after drug administration

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

    Time frame: up to 48 hours after drug administration

  5. MRTpo (mean residence time of the analyte in the body after oral administration)

    Time frame: up to 48 hours after drug administration

  6. CL/F (apparent clearance of the analyte in the plasma after extravascular administration)

    Time frame: up to 48 hours after drug administration

  7. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)

    Time frame: up to 48 hours after drug administration

  8. Fluctuation parameter Cmax/C24 ratio

    Time frame: up to 48 hours after drug administration

  9. Maximum prolongation of blood coagulation time

    by HepTest® (Haemachem Inc.)

    Time frame: up to 48 hours after drug administration

  10. Number of subjects with adverse events

    Time frame: up to 8 days after last drug administration

  11. Number of subjects with clinically significant findings in vital signs (blood pressure, pulse rate)

    Time frame: up to 8 days after last drug administration

  12. Number of subjects with clinically significant findings in ECG

    Time frame: up to 8 days after last drug administration

  13. Number of subjects with clinically significant findings in laboratory tests

    Time frame: up to 8 days after last drug administration

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

    Time frame: up to 8 days after last drug administration

  15. % Inhibition of Factor Xa

    by Russel's Viper Venom test (RVV)

    Time frame: up to 48 hours after 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 Aug 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02214953
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Aug 13, 2014
Start date
Oct 2007
Primary completion
Dec 2007
Last update
Aug 13, 2014
View the source record on ClinicalTrials.gov ↗

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