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Bioavailability of BI 1356 Administered With and Without Food to Healthy Male and Female Subjects

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ClinicalTrials.gov Identifier: NCT02183493
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To investigate the food effect on the relative bioavailability and pharmacokinetics of a 5 mg BI 1356 tablet administered as a single dose

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability of a 5 mg BI 1356 Tablet Administered With and Without Food to Healthy Male and Female Subjects in an Open, Randomised, Single Dose, Two-way Crossover, Phase I Trial
Study Start Date : October 2008
Actual Primary Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin

Arm Intervention/treatment
Experimental: Fed administration of BI 1356 Drug: BI 1356
Active Comparator: Fasted administration of BI 1356 Drug: BI 1356



Primary Outcome Measures :
  1. Area under the concentration-time curve of BI 1356 in plasma over the time interval from 0 to 72 h (AUC0-72) [ Time Frame: up to 72 hours after start of treatment ]
  2. Maximum measured concentration (Cmax) of BI 1356 in plasma [ Time Frame: up to 96 hours after start of treatment ]

Secondary Outcome Measures :
  1. Area under the concentration-time curve of BI 1356 in plasma at different time points [ Time Frame: up to 96 hours after start of treatment ]
  2. Time from dosing to the maximum concentration (tmax) of BI 1356 in plasma [ Time Frame: up to 96 hours after start of treatment ]
  3. Terminal elimination rate constant (λz) in plasma [ Time Frame: up to 96 hours after start of treatment ]
  4. Terminal half-life (t1/2) of BI 1356 in plasma [ Time Frame: up to 96 hours after start of treatment ]
  5. Mean residence time of BI 1356 in the body after oral administration (MRTpo) [ Time Frame: up to 96 hours after start of treatment ]
  6. Apparent clearance of BI 1356 in the plasma after extravascular administration (CL/F) [ Time Frame: up to 96 hours after start of treatment ]
  7. Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) [ Time Frame: up to 96 hours after start of treatment ]
  8. Number of patients with adverse events [ Time Frame: up to 11 weeks ]
  9. Assessment of tolerability on a 4-point scale by investigator [ Time Frame: 14 days after last study drug administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females according to the following criteria:

    -- 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 ≥ 18 and Age ≤ 50 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:

  • Any finding of the medical examination deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
  • Any evidence of a clinically relevant concomitant disease
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of the 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 relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  • Intake of drugs within one month or less than 10 half-lives of the respective drug prior to first study drug administration and during the trial except if a relevant interaction can be ruled out
  • Participation in another trial with an investigational drug within two months prior to first study drug 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 (average consumption of more than 20 g/day in females and 30 g/day in males)
  • Drug abuse
  • Blood donation (more than 100 mL within four weeks prior to the start of study)
  • 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 trial site
  • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
  • A history of additional risk factors for torsades de points (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

For female subjects:

  • Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 2 months after study completion
  • No adequate contraception during the study and until 2 months after study completion, i.e. not any of the following: implants, injectables, combined oral contraceptives, intrauterine device (IUD) , sexual abstinence for at least 1 month prior to enrolment, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who do not have a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to use an additional barrier method (e.g. condom, diaphragm with spermicide)
  • Lactation

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183493    
Other Study ID Numbers: 1218.34
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