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

NCT02183623 | Completed Phase 1

• 1 other identifier: 1218.9
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUCτ,ss (area under the concentration-time curve of simvastatin in plasma at steady state over a uniform dosing interval τ)

  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)

  up to 600 hours after first administration

Secondary Outcomes (13)

• Tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)

  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)

  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)

  up to 600 hours after first administration

• λz,ss (terminal rate constant in plasma at steady state)

  up to 600 hours after first administration

• t1/2,ss (terminal half-life of the analyte in plasma at steady state)

  up to 600 hours after first administration

Study Arms (1)

BI 1356 BS and Simvastatin

EXPERIMENTAL

Drug: Simvastatin; Drug: 10 mg BI 1356 BS

Interventions

Simvastatin DRUG

BI 1356 BS and Simvastatin

10 mg BI 1356 BS DRUG

BI 1356 BS and Simvastatin

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Simvastatin; Linagliptin

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 8, 2014
• Study Start: September 1, 2005
• Primary Completion: October 1, 2005
• Last Updated: July 8, 2014

Record last verified: 2014-07