Skip to main content
OpenTrials
Completed

NCT Number: NCT02268760

Safety, Tolerance, and Pharmacokinetics of BILN 2061 ZW in Healthy Male Subjects, Combined With Preliminary Evaluation of Food Effect

To assess the safety, tolerance and pharmacokinetics of 5 mg to 2400 mg BILN 2061 ZW

1. In rising single doses 2. With and without a 64 g fat breakfast at one selected dose

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male subjects as determined by results of screening
  • Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
  • Age ≥ 18 and ≤ 50 years
  • Broca ≥ - 20 % and ≤ + 20 %

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 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 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

Treatment and study plan

BILN 2061 ZW single rising doses

Drug

Placebo

Drug

BILN 2061 ZW fixed dose

Drug

standardized breakfast

Other

Primary outcomes

  1. Number of patients with clinically relevant changes in vital signs (systolic and diastolic blood pressure, pulse rate)

    Time frame: Pre-dose, up to 48 hours after drug administration

  2. Changes from baseline in laboratory tests

    Time frame: Pre-dose and 48 hours after drug administration

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

    Time frame: Pre-dose, up to 48 hours after drug administration

  4. Changes from baseline in physical examination

    Time frame: Pre-dose and 48 hours after drug administration

  5. Number of patients with adverse events

    Time frame: Up to 48 hours after drug administration

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

    Time frame: Up to 48 hours after drug administration

  7. Maximum concentration of the analyte in plasma after a single dose administration (Cmax)

    Time frame: up to 48 hours after drug administration

  8. Area under the concentration-time curve of the analyte in plasma from time 0 to infinity (AUC0-infinity)

    Time frame: up to 48 hours after drug administration

  9. Time to reach Cmax following a single dose administration (tmax)

    Time frame: up to 48 hours after drug administration

  10. Elimination half-life of the analyte in plasma (t1/2)

    Time frame: up to 48 hours after drug administration

  11. Total oral clearance of the analyte from plasma after oral administration, divided by F (bioavailability factor) (CL/F)

    Time frame: up to 48 hours after drug administration

  12. Total mean residence time of the analyte in plasma (MRT)

    Time frame: up to 48 hours after drug administration

  13. Apparent volume of distribution during the terminal elimination phase (Vz/F)

    Time frame: up to 48 hours after drug administration

  14. Amount of intact drug excreted in urine (Au)

    Time frame: up to 48 hours after drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of 5 mg, 20 mg, 60 mg, 100 mg, 200 mg, 400 mg, 600 mg, 800 mg, 1000 mg, 1200 mg, 1500 mg, 2000 mg and 2400 mg BILN 2061 ZW (PEG 400: Ethanol Solution) in Healthy Male Subjects, Combined With Preliminary Evaluation of Food Effect of the Dose of 200 mg (Two-Stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Part and Subsequent Open Intraindividual Comparison Part)

Important dates

Study start
2001
Primary completion
2001
First posted
Oct 20, 2014
Registry last updated
Oct 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.