Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability of BIBB 1464 (Tablet) in Hyperlipemic Healthy Male Subjects

NCT02229773 | Completed Phase 1

• 1 other identifier: 1178.2
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Lipid lowering effect, investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, monoepoxysqualene (MES) as marker), safety / tolerability and preliminary pharmacokinetics

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Percentage change of LDL plasma cholesterol

  baseline, 2 weeks

• Percentage change of total plasma cholesterol

  baseline, 2 weeks

Secondary Outcomes (11)

• Percentage change in lipid profile

  baseline, 1 week

• Number of patients with adverse events

  Up to day 42

• Number of patients with clinical significant findings in eye lens opacification

  Up to day 42

• Number of patients with clinical significant findings in laboratory parameters

  Up to day 28

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

  Up to day 28

Study Arms (5)

BIBB 1464 MS low dose

EXPERIMENTAL

Drug: BIBB 1464 MS low dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Pravastatin

ACTIVE COMPARATOR

Drug: Pravastatin

BIBB 1464 MS medium dose

EXPERIMENTAL

Drug: BIBB 1464 MS medium dose

BIBB 1464 MS high dose

EXPERIMENTAL

Drug: BIBB 1464 MS high dose

Interventions

BIBB 1464 MS low dose DRUG

BIBB 1464 MS low dose

Placebo DRUG

Placebo

Pravastatin DRUG

Pravastatin

BIBB 1464 MS medium dose DRUG

BIBB 1464 MS medium dose

BIBB 1464 MS high dose DRUG

BIBB 1464 MS high dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male Caucasian subjects as determined by results of screening
• Written informed consent in accordance with GCP and local legislation given
• Age \>= 18 and \<= 65 years
• Broca \>= - 20% and \<= + 30%
• LDL-cholesterol level \>= 3.3 mmol/L at pre-screening and at the two screening visits

You may not qualify if:

• 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 (including thyroid) disorder
• Surgery of the gastro-intestinal tract (except appendectomy)
• Disease of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History or orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged 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
• Alcohol abuse (\>60/g/day)
• Drug abuse
• Blood donation (\>400ml \<=1 month prior to administration)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Pravastatin

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 1, 2014
• Study Start: January 1, 2000
• Primary Completion: May 1, 2000
• Last Updated: September 1, 2014

Record last verified: 2014-08