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CompletedNCT02256787Updated Oct 6, 2014

Safety, Tolerance, and Pharmacokinetics of Single Rising Oral Doses of BILB 1941 ZW Solution in Healthy Male Subjects, Followed With Bioavailability Comparison of BILB 1941 ZW Tablet and Solution Formulation Administered With or Without Food

A Phase 1 interventional study of BILB 1941 ZW - single rising dose part and Placebo in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-06.

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

Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

The objective of the current study was to investigate the safety, tolerability, and pharmacokinetics of BILB 1941 ZW following the administration of single rising doses from 5 mg to 300 mg. In addition the bioavailability of the 60 mg dose given fasted and after a high-fat breakfast was to be be investigated

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
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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 ECG, clinical laboratory tests:

    1.1 No finding deviating from normal and of clinical relevance

    1.2 No evidence of a clinically relevant concomitant disease

  2. Age ≥18 and Age ≤50 years, BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
  3. 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:

  • Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
  • History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a clinical history of viral hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection
  • History of orthostatic hypotension, fainting spells and blackouts
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • Chronic or relevant 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 1 month prior to administration
  • Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
  • Participation in another trial with an investigational drug within 1 month prior to administration or during the trial
  • Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on trial days
  • Alcohol abuse (> 60 g/day)
  • Drug abuse
  • Blood donation of more than 100 mL within 1 month prior to administration or during the trial
  • Excessive physical activities within 5 days prior to administration or during the trial
  • Any laboratory value outside the clinically accepted reference range and of clinical relevance
  • History of any familial bleeding disorder
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
56 participants (actual)

Study arms

  • Experimental
    BILB 1941 ZW - single rising dose

    Single rising dose part

    Drug: BILB 1941 ZW - single rising dose part

  • Placebo comparator
    Placebo

    Single rising dose part

    Drug: Placebo

  • Experimental
    BILB 1941 ZW - tablet - fasted

    Relative bioavailability: The oral solution fasted should be compared with the solid form fasted and after a standardized breakfast

    Drug: BILB 1941 ZW - tablet

  • Experimental
    BILB 1941 ZW - solution

    Relative bioavailability: The oral solution fasted should be compared with the solid form fasted and after a standardized breakfast

    Drug: BILB 1941 ZW - solution

  • Experimental
    BILB 1941 ZW - tablet - fed

    Relative bioavailability: The oral solution fasted should be compared with the solid form fasted and after a standardized breakfast

    Drug: BILB 1941 ZW - tablet · Other: standardized breakfast

Interventions

  • DrugBILB 1941 ZW - single rising dose part
  • DrugPlacebo
  • DrugBILB 1941 ZW - solution
  • DrugBILB 1941 ZW - tablet
  • Otherstandardized breakfast
06

What researchers measure

Primary outcomes

  1. Number of subjects with abnormal findings in physical examination

    Time frame: up to 48 hours following drug administration

  2. Number of subjects with abnormal changes in laboratory parameters

    Time frame: up to 48 hours following drug administration

  3. Number of subjects with clinically significant changes in vital signs

    Blood pressure, Pulse Rate

    Time frame: up to 48 hours following drug administration

  4. Number of subjects with adverse events

    Time frame: up to 48 hours following drug administration

  5. Number of subjects with clinically significant changes in 12-lead ECG (electrocardiogram)

    Time frame: up to 48 hours following drug administration

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

    Time frame: after 48 hours following drug administration

Secondary outcomes

  1. Cmax (maximum concentration of the analyte in plasma)

    Time frame: up to 48 hours following drug administration

  2. tmax (time from dosing to maximum concentration)

    Time frame: up to 48 hours following drug administration

  3. 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 following drug administration

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

    Time frame: up to 48 hours following drug administration

  5. λz (terminal rate constant in plasma)

    Time frame: up to 48 hours following drug administration

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

    Time frame: up to 48 hours following drug administration

  7. MRT (Mean time of residence of drug molecules in the body after intravascular administration)

    Time frame: up to 48 hours following drug administration

  8. Vz/F (Apparent volume of distribution during the terminal phase after extravascular administration)

    Time frame: up to 48 hours following 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 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02256787
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 6, 2014
Start date
Jan 2004
Primary completion
Sep 2004
Last update
Oct 6, 2014
View the source record on ClinicalTrials.gov ↗

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