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Pharmacokinetics of Single and Multiple Oral Doses of BI 1356 in Healthy Chinese Volunteers

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ClinicalTrials.gov Identifier: NCT02183532
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to investigate the pharmacokinetics of BI 1356 after single and multiple oral doses of 5 mg in Chinese healthy subjects

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Single and Multiple Oral Doses of 5 mg BI 1356 in Healthy Chinese Volunteers
Study Start Date : July 2009
Actual Primary Completion Date : July 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin

Arm Intervention/treatment
Experimental: BI 1356 BS Drug: BI 1356 BS
single dose

Drug: BI 1356 BS
multiple doses




Primary Outcome Measures :
  1. Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state) [ Time Frame: up to day 19 ]
  2. AUCτ (Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: up to day 19 ]

Secondary Outcome Measures :
  1. Cmax (Maximum measured concentration of the analyte in plasma) at different time points after single and multiple doses [ Time Frame: up to day 19 ]
  2. tmax (Time from dosing to maximum measured concentration) at different time points after single and multiple doses [ Time Frame: up to day 19 ]
  3. AUC0-infinity (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration) [ Time Frame: up to day 7 ]
  4. AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of last quantifiable analyte plasma concentration after single dose administration) [ Time Frame: up to day 7 ]
  5. AUC0-24 (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours after single dose administration) [ Time Frame: up to 24 h after single dose administration ]
  6. AUC0-72 (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours after single dose administration) [ Time Frame: up to 72 h after single dose administration ]
  7. λz (Terminal rate constant in plasma) at different time points after single and multiple doses [ Time Frame: up to day 19 ]
  8. t1/2 (Terminal half-life of the analyte in plasma) at different time points after single and multiple doses [ Time Frame: up to day 19 ]
  9. MRTpo (Mean residence time of the analyte in the body) at different time points after single and multiple doses [ Time Frame: up to day 19 ]
  10. CL/F (Apparent clearance of the analyte in plasma after extravascular administration) at different time points after single and multiple doses [ Time Frame: up to day 19 ]
  11. Vz/F (Apparent volume of distribution during the terminal phase λz following extravascular administration) at different time points after single and multiple doses [ Time Frame: up to day 19 ]
  12. Aet1-t2 (Amount of analyte that is eliminated in urine from time point t1 to time point t2) at different time points after single and multiple doses [ Time Frame: up to 168 h after first dose and up to 24 h after last dose ]
  13. fet1-t2 (Fraction of analyte eliminated in urine from time point t1 to time point t2) at different time points after single and multiple doses [ Time Frame: up to 168 h after first dose and up to 24 h after last dose ]
  14. Cmin,ss (Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) for multiple doses [ Time Frame: up to 144 h after last dose ]
  15. Cavg,ss (Average concentration of the analyte in plasma at steady state) [ Time Frame: up to 144 h after last dose ]
  16. AUCτ,ss (Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: up to 144 h after last dose ]
  17. CLRt1-t2,ss (Renal clearance of the analyte at steady state from time point t1 to time point t2) [ Time Frame: up to 144 h after last dose ]
  18. Cpre (Predose concentration of the analyte in plasma) at different time points [ Time Frame: up to 120 h after first of multiple doses ]
  19. PTF (Peak-Trough Fluctuation) [ Time Frame: up to 120 h after first of multiple doses ]
  20. RA,Cmax (Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ) based on Cmax [ Time Frame: up to day 19 ]
  21. RA,AUC (Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ) based on AUCτ [ Time Frame: up to day 19 ]
  22. Number of patients with adverse events [ Time Frame: up to 28 days ]
  23. Number of patients with abnormal findings in physical examination [ Time Frame: up to 25 days ]
  24. Number of patients with abnormal changes in laboratory parameters [ Time Frame: up to 25 days ]
  25. Number of patients with clinically significant changes in Vital signs (blood pressure [BP], pulse rate [PR]) [ Time Frame: up to 25 days ]
  26. Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG) [ Time Frame: up to 25 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Male and female Chinese healthy volunteers who meet the criteria below:

  • Persons without clinically remarkable findings or clinically evident complications based on their concurrent illness, past medical history, physical examination, vital signs (blood pressure, pulse rate, and body temperature), 12-lead Electrocardiogram (ECG), and laboratory test results
  • Age ≥18 and Age ≤45 years
  • Body weight ≥50 kg with BMI ≥19 and BMI ≤24 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:

  • Persons who deviate from the norm, and who show clinical findings (Blood pressure (BP), Heart rate (HR), and ECG) on consultation
  • Persons with any clinically significant complications
  • Persons with gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immune, or hormonal disorders
  • Persons with central nervous system disorders (e.g., epilepsy), mental disorders, or neurological disorders
  • Persons with a history of significant orthostatic hypotension, syncopal attacks, or blackouts
  • Persons with chronic infection or severe acute infection
  • Persons with a history of severe allergy/hypersensitivity (including allergies to drugs or inactive ingredients)
  • Persons who will have received a drug with a long half-life (more than 24 hours) within the month before treatment in this study, within a period 10 times longer than the half-life of each drug, or during the study
  • Persons who will have received a drug that may theoretically affect the study results based on the information obtained at the time of preparation of the protocol, within the 10 days before treatment or during the study (e.g inhibitors or inducers of Pgp or CYP 3A4)
  • Persons who will have participated in another trial of an investigational drug within the 4 months before treatment or during the study
  • Smokers (who smoke more than 10 cigarettes, or 3 cigars, or 3 pipes per day)
  • Persons who cannot abstain from smoking throughout the study
  • Persons who undoubtedly abuse alcohol
  • Persons who abuse drugs
  • Persons who donate blood of 100 mL or more within the 4 weeks before treatment
  • Persons who perform rigorous exercise (within the week before treatment or during the study)
  • Persons with any laboratory test result outside the reference range and for whom the result is considered a clinically significant change
  • Persons who cannot obey the dieting rules of the study centre
  • Persons with any ECG value outside the reference range and who are of clinical importance. Examples include, but are not limited to, QRS interval >120 ms.
  • Pre-menopausal women (last menstruation <1 year prior to the date of informed consent) who:

    • are nursing or pregnant
    • or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to periodic pregnancy testing during their participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made.

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183532    
Other Study ID Numbers: 1218.58
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
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action