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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

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ClinicalTrials.gov Identifier: NCT02183623
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Investigation of the multiple dose pharmacokinetics, safety and tolerability of simvastatin and simvastatin acid with and without concomitant administration of BI 1356 BS

Condition or disease Intervention/treatment Phase
Healthy Drug: Simvastatin Drug: 10 mg BI 1356 BS Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : September 2005
Actual Primary Completion Date : October 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BI 1356 BS and Simvastatin Drug: Simvastatin
Drug: 10 mg BI 1356 BS



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. λz,ss (terminal rate constant in plasma at steady state) [ Time Frame: up to 600 hours after first administration ]
  5. t1/2,ss (terminal half-life of the analyte in plasma at steady state) [ Time Frame: up to 600 hours after first administration ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. 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 ]
  11. Number of patients with adverse events [ Time Frame: up to day 30 ]
  12. Clinically relevant changes in clinical laboratory values [ Time Frame: up to day 30 ]
  13. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: up to day 30 ]


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183623    
Other Study ID Numbers: 1218.9
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Linagliptin
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors