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CompletedNCT02244203Updated Sep 19, 2014

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 60732 in Healthy Male Volunteers

A Phase 1 interventional study of BI 60732 and Placebo in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-19.

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

Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

Single Rising Dose (SRD) study: First evaluation of safety, tolerability, pharmacokinetics and pharmacodynamics of BI 60732

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 45 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 ≤ 45 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 deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
  • 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 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 within one month or less than 10 half-lives of the respective drug prior to first study drug administration except if a relevant interaction can be ruled out
  • Participation in another trial with an investigational drug within 2 months prior to first study drug administration
  • Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
  • Alcohol abuse (average consumption of more than 30 g / day)
  • Drug abuse
  • Blood donation (more than 100 mL within four weeks prior to the start of study)
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of trial site
  • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
  • A history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
  • Anaemia at screening

  • Subjects who in the investigator's judgement are perceived as having an increased risk of bleeding, for example because of:

    • Hemorrhagic disorders or bleeding diathesis
    • Occult blood in faeces or haematuria
    • Trauma or surgery within the last month or as long as an excessive risk of bleeding persists after these events, or planned surgery during trial participation
    • History of arteriovenous malformation or aneurysm
    • History of gastroduodenal ulcer disease or gastrointestinal haemorrhage
    • History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding
    • Use of drugs that may interfere with haemostasis during trial conduct (e.g. acetylsalicylic acid or other non-steroidal anti-inflammatory drugs)
    • Thrombocytopenia (platelet count \< 100/nL)
05

Study design

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

Study arms

  • Experimental
    Single rising doses of BI 60732

    Drug: BI 60732

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugBI 60732
  • DrugPlacebo
06

What researchers measure

Primary outcomes

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

    Time frame: up to day 21 after start of treatment

  2. Number of patients with clinically relevant changes in 12-lead ECG

    Time frame: up to day 21 after start of treatment

  3. Number of patients with clinically relevant changes in laboratory parameters

    Time frame: up to day 21 after start of treatment

  4. Number of patients with clinically relevant changes in coagulation parameters

    Parameters: * Activated partial thromboplastin time (aPTT) * Prothrombin time (PT) * HepTest®

    Time frame: up to 72 hours after start of treatment

  5. Number of patients with adverse events

    Time frame: up to 6 weeks

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

    Time frame: up to 21 days after start of treatment

Secondary outcomes

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

    Time frame: up to 264 hours after start of treatment

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

    Time frame: up to 264 hours after start of treatment

  3. Area under the concentration-time curve of the analyte in plasma (AUC)

    Time frame: up to 264 hours after start of treatment

  4. Terminal rate constant of the analyte in plasma (λz)

    Time frame: up to 264 hours after start of treatment

  5. Terminal half-life of the analyte in plasma (t1/2)

    Time frame: up to 264 hours after start of treatment

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

    Time frame: up to 264 hours after start of treatment

  7. Apparent clearance of the analyte in plasma after extravascular administration (CL/F)

    Time frame: up to 264 hours after start of treatment

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

    Time frame: up to 264 hours after start of treatment

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

    Time frame: up to 264 hours after start of treatment

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

    Time frame: Pre-dose, up to 264 hours after start of treatment

  11. Changes in activated partial thromboplastin time (aPTT)

    Time frame: Pre-dose, up to 72 hours after start of treatment

  12. Changes in prothrombin time (PT)

    Time frame: Pre-dose, up to 72 hours after start of treatment

  13. Prolongation of coagulation time by Heptest®

    Time frame: up to 72 hours after start of treatment

  14. Inhibition of FXa activity

    Russel's Viper Venom (RVV)

    Time frame: Pre-dose up to 168 hours after start of treatment

  15. Percentage inhibition of endogenous thrombin generation

    Time frame: up to 24 hours after start of treatment

  16. Percentage peak inhibition of thrombin generation

    Time frame: up to 24 hours after start of treatment

  17. Relative prolongation of time to maximum inhibition of thrombin generation

    Time frame: up to 24 hours after start of treatment

  18. Relative prolongation of lag time of thrombin generation

    Time frame: up to 24 hours after start of treatment

  19. Maximum effect (Emax)

    Time frame: up to 168 hours after start of treatment

  20. Time to maximum effect (tmax)

    Time frame: up to 168 hours after start of treatment

  21. Area under the effect curve (AUEC)

    Time frame: up to 168 hours after start of treatment

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 Sep 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02244203
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Sep 19, 2014
Start date
Feb 2009
Primary completion
Jul 2009
Last update
Sep 19, 2014
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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