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CompletedNCT02182297Updated Jul 18, 2014

Safety, Tolerability, and Pharmacokinetics of BI 201335 NA in Healthy Male Subjects

A Phase 1 interventional study of BI 201335 NA in single rising doses and Placebo in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 20 Years to 35 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
50
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Male
01

Study summary

The objective of this trial was to investigate safety, tolerability, and pharmacokinetics of BI 201335 ZW after administration of single rising doses from 40 mg to 480 mg of BI 201335 NA in healthy Japanese male volunteers.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.

Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.

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

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Subjects will be healthy male volunteers who meet the criteria below:

  • Persons without clinically remarkable findings or clinically evident complications based on their concurrent illness, past medical history, physical examination, vital signs (blood pressure, pulse rate, and body temperature), 12-lead ECG, and laboratory test results
  • Persons who are 20 or older and 35 or younger
  • Persons with body mass index (BMI) of 18.5 kg/m2 or more and 25.0 kg/m2 less
  • Persons who are willing to participate in this trial before study initiation and who give their written consent in accordance with the GCP (Good Clinical Practice)

Exclusion criteria

Exclusion Criteria:

  • Any finding of the medical examination (including blood pressure, pulse rate, body temperature, and ECG) deviating from normal and of clinical relevance
  • Any evidence of a clinically relevant concomitant disease
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
  • Prior history of jaundice
  • Surgery of the gastrointestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • History of relevant orthostatic hypotension, fainting spells, or blackouts
  • 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 at least 1 month or less than 10 half-lives of the respective drug prior to administration or during the trial
  • Use of any drugs within 10 days prior to administration or during the trial
  • Participation in another trial with an investigational product within four months prior to administration or during the trial
  • Smoker (>10 cigarettes, >3 cigars or >3 pipes/day)
  • Inability to refrain from smoking on trial days (during hospitalisation and end of trial)
  • Alcohol abuse (more than 60 g/day)
  • Drug abuse
  • Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
  • Excessive physical activities (within 1 week prior to administration or during the trial)
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of the trial site
  • A history of additional risk factors for torsades de pointe (e.g., heart failure, hypokalemia, and family history of long QT syndrome)
  • The use of concomitant medications that prolong the QT/corrected QT interval
05

Study design

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

Study arms

  • Experimental
    BI 201335 NA in single rising doses

    Drug: BI 201335 NA in single rising doses

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Number of patients with abnormal findings in physical examination

    Time frame: Baseline and within 7 days after last trial procedure

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

    Time frame: Baseline, pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose and day 12

  3. Number of patients with abnormal findings in 12-lead electrocardiography (ECG)

    Time frame: Baseline, pre-dose and 1, 2, 4, 6, 8, 24, 48, 72 and 96 hours post-dose and day 12

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

    Time frame: Baseline, pre-dose and 24, 48, 72 and 96 hours post-dose and day 12

  5. Number of patients with adverse events

    Time frame: up to day 12

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

    Time frame: day 12 (within 7 days after last trial procedure)

Secondary outcomes

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

    Time frame: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

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

    Time frame: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 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 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 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 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  5. λz (terminal elimination rate constant in plasma)

    Time frame: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

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

    Time frame: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  7. MRTpo (mean residence time of the analyte in the body after po administration)

    Time frame: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

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

    Time frame: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

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

    Time frame: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  10. Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)

    Time frame: 0-4, 4-12, 12-24, 24-48, 48-72 and 72-96 hours post-dose

  11. fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)

    Time frame: 0-4, 4-12, 12-24, 24-48, 48-72 and 72-96 hours post-dose

  12. CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)

    Time frame: 0-4, 4-12, 12-24, 24-48, 48-72 and 72-96 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
NCT02182297
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jul 8, 2014
Start date
Apr 2008
Primary completion
Dec 2008
Last update
Jul 18, 2014
View the source record on ClinicalTrials.gov ↗

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