- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02183623
The Effect of Multiple Oral Doses of BI 1356 BS on Pharmacokinetics, Safety and Tolerability of Multiple Oral Doses of Simvastatin and on the Pharmacokinetics of Its Metabolite Simvastatin Acid in Healthy Male Volunteers
July 7, 2014 updated by: Boehringer Ingelheim
The Effect of Multiple Oral Doses of BI 1356 BS as Tablets Once Daily for Six Days on the Pharmacokinetics, Safety and Tolerability of Multiple Oral Doses of 40 mg Simvastatin Given Once Daily for 20 Days and on the Pharmacokinetics of Its Metabolite Simvastatin Acid. An Open-label Study in Healthy Male Volunteers.
Investigation of the multiple dose pharmacokinetics, safety and tolerability of simvastatin and simvastatin acid with and without concomitant administration of BI 1356 BS
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male subjects according to the following criteria: No findings deviating from normal and of clinical relevance as well as no evidence of a clinically relevant concomitant disease based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
- Age ≥21 and Age ≤65 years
- BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Exclusion Criteria:
- 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-neurological disorders
- History of relevant 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 by the investigator
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs, including herbal products, which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of study centre
- Not willing to use adequate contraception (condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole study period from the time of the first intake of study drug until one month after the last intake
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BI 1356 BS and Simvastatin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUCτ,ss (area under the concentration-time curve of simvastatin in plasma at steady state over a uniform dosing interval τ)
Time Frame: up to 600 hours after first administration
|
up to 600 hours after first administration
|
Cmax,ss (maximum measured concentration of simvastatin in plasma at steady state over a uniform dosing interval τ)
Time Frame: up to 600 hours after first administration
|
up to 600 hours after first administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)
Time Frame: up to 600 hours after first administration
|
up to 600 hours after first administration
|
Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time Frame: up to 600 hours after first administration
|
up to 600 hours after first administration
|
Cpre,N (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N)
Time Frame: up to 600 hours after first administration
|
up to 600 hours after first administration
|
λz,ss (terminal rate constant in plasma at steady state)
Time Frame: up to 600 hours after first administration
|
up to 600 hours after first administration
|
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Time Frame: up to 600 hours after first administration
|
up to 600 hours after first administration
|
MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)
Time Frame: up to 600 hours after first administration
|
up to 600 hours after first administration
|
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Time Frame: up to 600 hours after first administration
|
up to 600 hours after first administration
|
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Time Frame: up to 600 hours after first administration
|
up to 600 hours after first administration
|
AUCτ,ss (area under the concentration-time curve of simvastatin acid and BI 1356 BS in plasma at steady state over a uniform dosing interval τ)
Time Frame: up to 600 hours after first administration
|
up to 600 hours after first administration
|
Cmax,ss (maximum measured concentration of simvastatin acid and BI 1356 BS in plasma at steady state over a uniform dosing interval τ)
Time Frame: up to 600 hours after first administration
|
up to 600 hours after first administration
|
Number of patients with adverse events
Time Frame: up to day 30
|
up to day 30
|
Clinically relevant changes in clinical laboratory values
Time Frame: up to day 30
|
up to day 30
|
Assessment of tolerability by investigator on a 4-point scale
Time Frame: up to day 30
|
up to day 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
October 1, 2005
Study Registration Dates
First Submitted
July 7, 2014
First Submitted That Met QC Criteria
July 7, 2014
First Posted (Estimate)
July 8, 2014
Study Record Updates
Last Update Posted (Estimate)
July 8, 2014
Last Update Submitted That Met QC Criteria
July 7, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Linagliptin
- Simvastatin
Other Study ID Numbers
- 1218.9
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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