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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1356 BS Administered to Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT02173665
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The objective of the current study was to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1356 BS.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 1356 BS - Powder in bottle (PIB) Drug: BI 1356 BS - Tablet Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1356 BS as a Solution at Dose Levels 2.5 -5 mg and Tablets at Dose Levels 25 - 600 mg Administered to Healthy Male Subjects. A Randomised, Double-blind, Placebo-controlled Trial, Including an Intra-subject Bioavailability Comparison of 100 mg BI 1356 BS as Tablet and as Solution. BI 1356 BS as Tablet and as Solution
Study Start Date : October 2004
Actual Primary Completion Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin

Arm Intervention/treatment
Experimental: BI 1356 BS - Powder in bottle (PIB) Drug: BI 1356 BS - Powder in bottle (PIB)
Experimental: BI 1356 BS - Tablet Drug: BI 1356 BS - Tablet
Active Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: up to 30 days ]
  2. Number of patients with abnormal findings in physical examination [ Time Frame: Screening, up to 16 days after drug administration ]
  3. Number of patients with clinically significant changes in vital signs (blood pressure [BP], heart rate [HR]) [ Time Frame: Screening, up to 16 days after drug administration ]
  4. Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG) [ Time Frame: Screening, up to 16 days after drug administration ]
  5. Number of patients with abnormal changes in laboratory parameters [ Time Frame: Screening, up to 16 days after drug administration ]
  6. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: up to 16 days after drug administration ]

Secondary Outcome Measures :
  1. Cmax (maximum concentration of the analyte in plasma) [ Time Frame: predose, up to 192 h following drug administration ]
  2. tmax (time from dosing to maximum concentration) [ Time Frame: predose, up to 192 h following drug administration ]
  3. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: predose, up to 192 h following drug administration ]
  4. %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) [ Time Frame: predose, up to 192 h following drug administration ]
  5. AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: predose, up to 192 h following drug administration ]
  6. λz (terminal rate constant in plasma) [ Time Frame: predose, up to 192 h following drug administration ]
  7. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: predose, up to 192 h following drug administration ]
  8. MRTpo (mean residence time of the analyte in the body after po administration) [ Time Frame: predose, up to 192 h following drug administration ]
  9. CL/F (total clearance of the analyte in the plasma after extravascular administration) [ Time Frame: predose, up to 192 h following drug administration ]
  10. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: predose, up to 192 h following drug administration ]
  11. Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2) [ Time Frame: up to 120 h following drug administration ]
  12. fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) [ Time Frame: up to 120 h following drug administration ]
  13. CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) [ Time Frame: up to 120 h following drug administration ]
  14. Changes of Dipeptidyl-Peptidase IV (DPP-IV) activity in plasma [ Time Frame: predose, up to 96 h following drug administration ]


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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 males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood pressure (BP), Heart Rate (HR), 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:

  • Any finding of the medical examination (including BP, HR and ECG) deviating from normal and of clinical relevance
  • Any evidence of a clinically relevant concomitant disease
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • 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 the drug or its excipients and lactose intolerance)
  • 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 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
  • Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval > 110 ms or QTcB > 450 ms or QT >500 ms

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02173665     History of Changes
Other Study ID Numbers: 1218.1
First Posted: June 25, 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