HealthyPhase 1NCT02266485
Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability of BIBB 515 BS or Pravastatin in Hyperlipemic Healthy Male Subjects
A Phase 1 study testing BIBB 515 BS and Pravastatin in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, MES as marker), effect on routine lipid profile parameters, safety and preliminary pharmacokinetics Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIBB 515 BS and Pravastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 1998to Sep 1998
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
About this study
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])
Investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, MES as marker), effect on routine lipid profile parameters, safety and preliminary pharmacokinetics
- Conditions
- Healthy
- Being tested
- BIBB 515 BS, Pravastatin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBB 515 BSDrug
PravastatinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBB 515 BS | Experimental | Not described Receives: Drug: BIBB 515 BS |
| Pravastatin | Active comparator | Not described Receives: Drug: Pravastatin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage changes in total-cholesterol
Measured: Pre-dose, up to day 15
Percentage changes in low density lipoprotein (LDL) - cholesterol
Measured: Pre-dose, up to day 15
Percentage changes in high density lipoprotein (HDL) - cholesterol
Measured: Pre-dose, up to day 15
Percentage changes in apo-lipoprotein B
Measured: Pre-dose, up to day 15
Percentage changes in lipoprotein (a)
Measured: Pre-dose, up to day 15
Percentage changes in triglycerides
Measured: Pre-dose, up to day 15
Maximum concentration of the analyte in plasma at different time points (Cmax)
Measured: Up 336 hours after first drug administration
Time to reach maximum concentration of the analyte in plasma at different time points (tmax)
Measured: Up 336 hours after first drug administration
Apparent terminal elimination half-life of the analyte in plasma (t1/2)
Measured: Up 336 hours after first drug administration
Area under the concentration-time curve of the analyte in plasma at different time points (AUC)
Measured: Up 336 hours after first drug administration
Total mean residence time of the analyte in the body (MRTtot)
Measured: Up 336 hours after first drug administration
Apparent clearance of the analyte in plasma after extravascular multiple dose administration (CL/f)
Measured: Up 336 hours after first drug administration
Apparent volume of distribution of the analyte during the terminal phase (Vz/f)
Measured: Up 336 hours after first drug administration
Terminal rate constant of the analyte in plasma (λz)
Measured: Up 336 hours after first drug administration
Number of participants with clinically relevant changes from baseline in physical examination
Measured: Pre-dose and day 15
Number of participants with clinically relevant changes from baseline in 12-lead ECG
Measured: Pre-dose and day 15
Number of participants with clinically relevant changes from baseline in lens examination
Measured: Pre-dose and day 15
Number of participants with clinically relevant changes in vital signs (blood pressure, pulse rate, body weight)
Measured: Pre-dose, up to 324 hours after first drug administration
Number of participants with clinically relevant changes in laboratory parameters
Measured: Pre-dose, up to 324 hours after first drug administration
Number of participants with adverse events
Measured: Up to 1 day after last drug administration
Global clinical assessment by the investigator
Measured: On day 15 after first drug administration
Monoepoxy-squalene (MES) plasma concentration at different time points
as surrogate marker for squalene inhibition
Measured: Pre-dose, up to day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startJul 1998
- Primary completionSep 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266485
- Sponsor's protocol ID
- 525.3
- Status last verified
- Oct 2014
- First submitted
- 16 Oct 2014
- Last updated
- 17 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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])
- ClinicalTrials.gov ID
- NCT02266485
- Acronym / sponsor ID
- 525.3
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 1998
- Primary completion
- Sep 1998 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, MES as marker), effect on routine lipid profile parameters, safety and preliminary pharmacokinetics
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIBB 515 BS | Experimental | Drug: BIBB 515 BS |
| Pravastatin | Active comparator | Drug: Pravastatin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIBB 515 BS | Drug | BIBB 515 BS |
| Pravastatin | Drug | Pravastatin |
| Placebo | Drug | Placebo |
Primary outcome
Percentage changes in total-cholesterol
Time frame: Pre-dose, up to day 15
Percentage changes in low density lipoprotein (LDL) - cholesterol
Time frame: Pre-dose, up to day 15
Percentage changes in high density lipoprotein (HDL) - cholesterol
Time frame: Pre-dose, up to day 15
Percentage changes in apo-lipoprotein B
Time frame: Pre-dose, up to day 15
Percentage changes in lipoprotein (a)
Time frame: Pre-dose, up to day 15
Percentage changes in triglycerides
Time frame: Pre-dose, up to day 15
Maximum concentration of the analyte in plasma at different time points (Cmax)
Time frame: Up 336 hours after first drug administration
Time to reach maximum concentration of the analyte in plasma at different time points (tmax)
Time frame: Up 336 hours after first drug administration
Apparent terminal elimination half-life of the analyte in plasma (t1/2)
Time frame: Up 336 hours after first drug administration
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
Total mean residence time of the analyte in the body (MRTtot)
Time frame: Up 336 hours after first drug administration
Apparent clearance of the analyte in plasma after extravascular multiple dose administration (CL/f)
Time frame: Up 336 hours after first drug administration
Apparent volume of distribution of the analyte during the terminal phase (Vz/f)
Time frame: Up 336 hours after first drug administration
Terminal rate constant of the analyte in plasma (λz)
Time frame: Up 336 hours after first drug administration
Number of participants with clinically relevant changes from baseline in physical examination
Time frame: Pre-dose and day 15
Number of participants with clinically relevant changes from baseline in 12-lead ECG
Time frame: Pre-dose and day 15
Number of participants with clinically relevant changes from baseline in lens examination
Time frame: Pre-dose and day 15
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
Number of participants with clinically relevant changes in laboratory parameters
Time frame: Pre-dose, up to 324 hours after first drug administration
Number of participants with adverse events
Time frame: Up to 1 day after last drug administration
Global clinical assessment by the investigator
Time frame: On day 15 after first drug administration
Monoepoxy-squalene (MES) plasma concentration at different time points
Time frame: Pre-dose, up to day 15
as surrogate marker for squalene inhibition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIBB 515 BS and Pravastatin in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage changes in total-cholesterol (time frame: Pre-dose, up to day 15). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2014.