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Completed

NCT Number: NCT02229838

Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of BIBB 1464 MS in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food

Safety, pharmacodynamics and pharmacokinetics of 0.25, 0.75, 2.0, 6.0, and 10 mg BIBB 1464 p.o once daily in a rising dose group-comparison (placebo controlled, double blind, randomized per dose level).

Relative Bioavailability of 0.75 mg or 2 mg or 6 mg ( tablet vs. solution, intraindividual comparison), preliminary assessment of food effects (interindividual comparison)

Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase).

MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase).

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Key information

Conditions

Healthy

Age range

19 year–54 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 subjects as determined by results of screening
  • Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
  • Age > 18 and < 55 years
  • Broca > - 20% and < + 20%

Exclusion criteria

  • Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance.
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal (including thyroid) disorder
  • Surgery of the gastro-intestinal tract (except appendectomy)
  • Disease of the central nervous system (such as epilepsy) or psychiatric 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) (<= 1 month prior to administration or during the trial)
  • Use of any drugs which might influence the result of the trial (<= 10 days prior to administration or during the trial)
  • Participation in another trial with an investigational drug (<= 2 month prior to administration or during the trial)
  • Smoker (> 10 cigarettes or > 3 cigars or >3 pipes/day)
  • Inability to refrain from smoking during the period of the study
  • Known alcohol (>60 g/day) or drug abuse
  • Blood donation (<=1 month prior to administration)
  • Excessive physical activities (<5 days prior to administration)
  • Any laboratory value outside the normal range of clinical relevance
  • History of hemorrhagic diatheses
  • History of gastro-intestinal ulcer, perforation or bleeding
  • History of bronchial asthma

Treatment and study plan

BIBB 1464 MS tablet

Drug

BIBB 1464 MS solution

Drug

BIBB 1464 MS placebo

Drug

Standard dinner

Other

Primary outcomes

  1. Maximum drug plasma concentration (Cmax)

    Time frame: Up to 38 hours after drug administration

  2. Time to reach the maximum concentration of the analyte in plasma (tmax)

    Time frame: Up to 38 hours after drug administration

  3. Total area under the plasma drug concentration-time curve (AUC)

    Time frame: Up to 38 hours after drug administration

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

    Time frame: Up to 38 hours after drug administration

  5. Total plasma clearance divided by the systemic availability factor (CL/f)

    Time frame: Up to 38 hours after drug administration

  6. Dose normalized AUC0-38h ( NAUC0-38h)

    Time frame: Up to 38 h after drug administration

  7. Mean residence time, total (MRTtot)

    Time frame: Up to 38 hours after drug administration

  8. Number of patients with adverse events

    Time frame: Up to 72 hours after last drug administration

  9. Number of patients with clinical significant findings in vital signs

    Time frame: Up to 38 hours after drug administration

  10. Number of patients with clinical significant findings in electrocardiogram (ECG)

    Time frame: Up to 38 hours after drug administration

  11. Number of patients with clinical significant findings in physical examination

    Time frame: Up to 38 hours after drug administration

  12. Investigator assessed tolerability on a 4 point scale

    Time frame: Up to 38 hours after drug administration

  13. Monoepoxysqualene (MES) plasma concentration

    Time frame: Up to 38 hours after drug administration

  14. Amount of drug excreted in urine

    Time frame: Up to 38 h after drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of 0.25 mg, 0.75 mg, 2 mg, 6 mg, and 10 mg BIBB 1464 MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase)

Important dates

Study start
1999
Primary completion
1999
First posted
Sep 1, 2014
Registry last updated
Sep 1, 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.

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