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TerminatedNCT02182271Updated Jul 18, 2014

Single Rising Dose Study of BI 201335 ZW in Healthy Male Subjects

A Phase 1 interventional study of BI 201335 ZW - single rising dose and Placebo in Healthy, sponsored by Boehringer Ingelheim. Terminated. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-18.

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

Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

The objective of the current study is to investigate safety, tolerability, and pharmacokinetics of BI 201335 ZW following administration of single rising doses from 5 mg to 1500 mg. In addition Two stage intra-subject bioavailability comparison of 600 mg BI 201335 ZW as a liquid formulation given with and without food.

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 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy males according to the following criteria based upon a complete medical history, including the physical examination, vital signs ((blood pressure (BP), pulse rate (HR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
  • Age ≥18 and Age ≤55 years
  • BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
  • Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
  • Willingness to abstain from alcohol from screening period until conclusion visit

Exclusion criteria

Exclusion Criteria:

  • Any finding of 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
  • 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 2 months 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 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
8 participants (actual)

Study arms

  • Experimental
    BI 201335 ZW - single rising dose

    Drug: BI 201335 ZW - single rising dose

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugBI 201335 ZW - single rising dose
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Number of patients with abnormal findings in physical examination

    Time frame: Baseline, day 3 of each treatment period, within 8 days after last administration

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

    Time frame: Baseline, day 1-3 of each treatment period, within 8 days after last administration

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

    Time frame: Baseline, day 1, 2 in treatment period, within 8 days after last administration

  4. Number of patients with abnormal changes in laboratory parameters

    Time frame: Baseline, day 1-3 of each treatment period, within 8 days after last administration

  5. Number of patients with adverse events

    Time frame: up to 13 days

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

    Time frame: on day 3 of each treatment period

Secondary outcomes

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

    Time frame: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose

  2. tmax (time from dosing to maximum concentration)

    Time frame: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose

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

    Time frame: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose

  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: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose

  5. λz (terminal elimination rate constant in plasma)

    Time frame: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose

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

    Time frame: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose

  7. MRTpo (Mean residence time of the analyte in the body after oral administration)

    Time frame: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose

  8. CL/F (apparent clearance of the analyte in the plasma after oral administration)

    Time frame: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose

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

    Time frame: pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose

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 Jul 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02182271
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jul 8, 2014
Start date
Oct 2004
Primary completion
Oct 2004
Last update
Jul 18, 2014
View the source record on ClinicalTrials.gov ↗

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