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OpenTrials
Completed

NCT Number: NCT02266485

Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability of BIBB 515 BS or Pravastatin in Hyperlipemic Healthy Male Subjects

Investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, MES as marker), effect on routine lipid profile parameters, safety and preliminary pharmacokinetics

Completed

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Key information

Conditions

Healthy

Age range

18 year–65 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 caucasian subjects as determined by results of screening
  • Written informed consent in accordance with good clinical practice (GCP) and local legislation given
  • Age ≥ 18 and ≤ 65 years
  • Broca ≥ - 20 % and ≤ + 30 %
  • Cholesterol level ≥ 5.4 mmol/l

Exclusion criteria

  • Any finding 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 disorders
  • Surgery of gastrointestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders
  • History of orthostatic hypotension, fainting spells or blackouts
  • Chronic or relevant acute infections
  • History of allergy/hypersensitivity (including drug allergy) which was 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 results of the trial (≤ 10 days prior to administration or during the trial)
  • Participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial)
  • Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
  • Inability to refrain from smoking on study days
  • Alcohol abuse (> 60 g/day)
  • Drug abuse
  • Blood donation > 100 ml (≤ 4 weeks prior to administration or during the trial)
  • Excessive physical activities (≤ 10 days prior to administration or during the trial)
  • Any laboratory value outside the reference range of clinical relevance
  • Abnormal findings at eye lens examination

Treatment and study plan

BIBB 515 BS

Drug

Pravastatin

Drug

Placebo

Drug

Primary outcomes

  1. Percentage changes in total-cholesterol

    Time frame: Pre-dose, up to day 15

  2. Percentage changes in low density lipoprotein (LDL) - cholesterol

    Time frame: Pre-dose, up to day 15

  3. Percentage changes in high density lipoprotein (HDL) - cholesterol

    Time frame: Pre-dose, up to day 15

  4. Percentage changes in apo-lipoprotein B

    Time frame: Pre-dose, up to day 15

  5. Percentage changes in lipoprotein (a)

    Time frame: Pre-dose, up to day 15

  6. Percentage changes in triglycerides

    Time frame: Pre-dose, up to day 15

  7. Maximum concentration of the analyte in plasma at different time points (Cmax)

    Time frame: Up 336 hours after first drug administration

  8. Time to reach maximum concentration of the analyte in plasma at different time points (tmax)

    Time frame: Up 336 hours after first drug administration

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

    Time frame: Up 336 hours after first drug administration

  10. Area under the concentration-time curve of the analyte in plasma at different time points (AUC)

    Time frame: Up 336 hours after first drug administration

  11. Total mean residence time of the analyte in the body (MRTtot)

    Time frame: Up 336 hours after first drug administration

  12. Apparent clearance of the analyte in plasma after extravascular multiple dose administration (CL/f)

    Time frame: Up 336 hours after first drug administration

  13. Apparent volume of distribution of the analyte during the terminal phase (Vz/f)

    Time frame: Up 336 hours after first drug administration

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

    Time frame: Up 336 hours after first drug administration

  15. Number of participants with clinically relevant changes from baseline in physical examination

    Time frame: Pre-dose and day 15

  16. Number of participants with clinically relevant changes from baseline in 12-lead ECG

    Time frame: Pre-dose and day 15

  17. Number of participants with clinically relevant changes from baseline in lens examination

    Time frame: Pre-dose and day 15

  18. Number of participants with clinically relevant changes in vital signs (blood pressure, pulse rate, body weight)

    Time frame: Pre-dose, up to 324 hours after first drug administration

  19. Number of participants with clinically relevant changes in laboratory parameters

    Time frame: Pre-dose, up to 324 hours after first drug administration

  20. Number of participants with adverse events

    Time frame: Up to 1 day after last drug administration

  21. Global clinical assessment by the investigator

    Time frame: On day 15 after first drug administration

  22. Monoepoxy-squalene (MES) plasma concentration at different time points

    Time frame: Pre-dose, up to day 15

    as surrogate marker for squalene inhibition

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability After Multiple Oral Doses of 2.5 mg o.d. BIBB 515 BS (Capsule) or Pravastatin 20 mg Over 2 Weeks in Hyperlipemic Healthy Male Subjects (Parallel Group Comparison, Randomized, Placebo Controlled, Partly Double Blind [Pravastatin Open])

Important dates

Study start
1998
Primary completion
1998
First posted
Oct 17, 2014
Registry last updated
Oct 17, 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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