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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02266485
• Collaborator: (none)
• Enrollment: 60
• Arms: 3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BIBB 515 BS; Drug: Pravastatin; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official 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])
• Study Start Date: Jul 1, 1998
• Actual Primary Completion Date: Sep 1, 1998

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BIBB 515 BS	Drug: BIBB 515 BS
Active Comparator: Pravastatin	Drug: Pravastatin
Placebo Comparator: Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Percentage changes in total-cholesterol [Pre-dose, up to day 15]

2. Percentage changes in low density lipoprotein (LDL) - cholesterol [Pre-dose, up to day 15]

3. Percentage changes in high density lipoprotein (HDL) - cholesterol [Pre-dose, up to day 15]

4. Percentage changes in apo-lipoprotein B [Pre-dose, up to day 15]

5. Percentage changes in lipoprotein (a) [Pre-dose, up to day 15]

6. Percentage changes in triglycerides [Pre-dose, up to day 15]

7. Maximum concentration of the analyte in plasma at different time points (Cmax) [Up 336 hours after first drug administration]

8. Time to reach maximum concentration of the analyte in plasma at different time points (tmax) [Up 336 hours after first drug administration]

9. Apparent terminal elimination half-life of the analyte in plasma (t1/2) [Up 336 hours after first drug administration]

10. Area under the concentration-time curve of the analyte in plasma at different time points (AUC) [Up 336 hours after first drug administration]

11. Total mean residence time of the analyte in the body (MRTtot) [Up 336 hours after first drug administration]

12. Apparent clearance of the analyte in plasma after extravascular multiple dose administration (CL/f) [Up 336 hours after first drug administration]

13. Apparent volume of distribution of the analyte during the terminal phase (Vz/f) [Up 336 hours after first drug administration]

14. Terminal rate constant of the analyte in plasma (λz) [Up 336 hours after first drug administration]

15. Number of participants with clinically relevant changes from baseline in physical examination [Pre-dose and day 15]

16. Number of participants with clinically relevant changes from baseline in 12-lead ECG [Pre-dose and day 15]

17. Number of participants with clinically relevant changes from baseline in lens examination [Pre-dose and day 15]

18. Number of participants with clinically relevant changes in vital signs (blood pressure, pulse rate, body weight) [Pre-dose, up to 324 hours after first drug administration]

19. Number of participants with clinically relevant changes in laboratory parameters [Pre-dose, up to 324 hours after first drug administration]

20. Number of participants with adverse events [Up to 1 day after last drug administration]

21. Global clinical assessment by the investigator [On day 15 after first drug administration]

22. Monoepoxy-squalene (MES) plasma concentration at different time points [Pre-dose, up to day 15]

    as surrogate marker for squalene inhibition

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02266485
• Other Study ID Numbers: 525.3
• First Posted: Oct 17, 2014
• Last Update Posted: Oct 17, 2014
• Last Verified: Oct 1, 2014

• Additional relevant MeSH terms: Pravastatin

Study Results

No Results Posted as of Oct 17, 2014