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CompletedNCT02182388Updated Jul 18, 2014

Single Rising Oral Doses of BI 207127 NA as Powder in the Bottle in Healthy Male Subjects

A Phase 1 interventional study of Placebo and BI 207127 NA powder for solution 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 2014-07-18.

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

Phase
Phase 1
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

The objective of this trial was to investigate the safety, tolerability, pharmacokinetics, and relative bioavailability of BI 207127 NA as powder in the bottle (PIB) and solid oral dosage form (tablets) without and with 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 50 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 (BP, PR), 12-lead ECG, clinical laboratory tests
  • Age ≥18 and Age ≤50 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 and the local legislation

Exclusion criteria

Exclusion Criteria:

  • Any finding of the medical examination (including BP, PR 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
  • Surgery of the gastrointestinal tract (except appendectomy)
  • Diseases of the central nerve 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 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 or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
  • Participation in another trial with an investigational drug within two months prior to administration or during the trial.
  • Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (more than 60 g/day)
  • Inability to refrain from alcohol on trial days
  • 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 comply with dietary regimen of trial site
  • Baseline prolongation of QTc interval >450 ms
  • A history of additional risk factors for TdP (Torsades de points) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
05

Study design

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

Study arms

  • Experimental
    BI 207127 NA

    single rising dose part

    Drug: BI 207127 NA powder for solution

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    BI 207127 NA, fasted or fed

    Drug: BI 207127 NA powder for solution · Drug: BI 207127 NA tablet

Interventions

  • DrugPlacebo
  • DrugBI 207127 NA powder for solution
  • DrugBI 207127 NA tablet
06

What researchers measure

Primary outcomes

  1. Number of patients with abnormal findings in physical examination

    Time frame: Baseline, within 14 days after last trial procedure

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

    Time frame: Baseline, up to 14 days after last trial procedure

  3. Number of patients with clinically relevant findings in 12-lead ECG (electrocardiogram)

    Time frame: Baseline, up to 14 days after last trial procedure

  4. Number of patients with abnormal changes in clinical laboratory tests

    Time frame: Baseline, up to 14 days after last trial procedure

  5. Number of patients with adverse events

    Time frame: up to 44 days

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

    Time frame: within 14 days after last trial procedure

Secondary outcomes

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

    Time frame: up to 72 hours after drug administration

  2. tmax (time from dosing to maximum measured concentration)

    Time frame: up to 72 hours after 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 72 hours after drug administration

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

    Time frame: up to 72 hours after drug administration

  5. λz (terminal rate constant in plasma)

    Time frame: up to 72 hours after drug administration

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

    Time frame: up to 72 hours after drug administration

  7. MRToral (mean residence time of the analyte in the body after oral administration)

    Time frame: up to 72 hours after drug administration

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

    Time frame: up to 72 hours after drug administration

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

    Time frame: up to 72 hours after drug administration

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

    Time frame: up to 48 hours after drug administration

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

    Time frame: up to 48 hours after drug administration

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

    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 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
NCT02182388
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jul 8, 2014
Start date
Jan 2007
Primary completion
May 2007
Last update
Jul 18, 2014
View the source record on ClinicalTrials.gov ↗

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