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Bioavailability of BI 1356 After Co-administration With Ritonavir Compared to the Bioavailability of BI 1356 Alone in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02183441
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 effect of the P-gp and cytochrome P450 (CYP) 3A4 inhibitor ritonavir on the pharmacokinetics of BI 1356

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability of a Single Oral Dose of BI 1356 (5 mg) After Co-administration With Multiple Oral Doses of Ritonavir (200 mg Bid for 3 Days) Compared to the Bioavailability of a Single Oral Dose of BI 1356 (5 mg) Alone in Healthy Male Volunteers (an Open-label, Randomized, Two-way Crossover, Clinical Phase I Study)
Study Start Date : April 2008
Actual Primary Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BI 1356 plus ritonavir
Treatment A: 3 days of ritonavir, 1 day BI 1356
Drug: BI 1356
Drug: Ritonavir
Other Name: Norvir®

Active Comparator: BI 1356
Treatment B: BI 1356 alone
Drug: BI 1356



Primary Outcome Measures :
  1. AUC0-24 (Area under the concentration-time curve of BI 1356 in plasma over the time interval from 0 to 24 hours) [ Time Frame: up to 24 hours after start of treatment ]
  2. Cmax (Maximum measured concentration of BI 1356 in plasma) [ Time Frame: up to 96 hours after start of treatment ]

Secondary Outcome Measures :
  1. AUC (Area under the concentration time curve of the analytes in plasma at different time points) [ Time Frame: up to 96 hours after start of treatment ]
  2. %AUCtz-∞ (Percentage of the extrapolated part of the area under the concentration time curve of the analytes in plasma from 0 to infinity) [ Time Frame: up to 96 hours after start of treatment ]
  3. tmax (Time from dosing to the maximum concentration of the analytes in plasma) [ Time Frame: up to 96 hours after start of treatment ]
  4. t1/2 (Terminal half-life of the analytes in plasma) [ Time Frame: up to 96 hours after start of treatment ]
  5. λz (Terminal rate constant of the analytes in plasma) [ Time Frame: up to 96 hours after start of treatment ]
  6. MRTpo (Mean residence time in the body after po administration of the analytes in plasma) [ Time Frame: up to 96 hours after start of treatment ]
  7. CL/F (Apparent clearance of BI 1356 in plasma after extravascular administration ) [ Time Frame: up to 96 hours after start of treatment ]
  8. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) of BI 1356 [ Time Frame: up to 96 hours after start of treatment ]
  9. Aet1-t2 (Amount of the analytes that is eliminated in urine from the time interval t1 to t2) [ Time Frame: up to 24 hours after start of treatment ]
  10. fet1-t2 (Fraction of BI 1356 excreted unchanged in urine from time point t1 to t2) [ Time Frame: up to 24 hours after start of treatment ]
  11. CLR,t1-t2 (Renal clearance of the analytes in plasma) [ Time Frame: up to 24 hours after start of treatment ]
  12. Cmax (Maximum measured concentration of CD 1750 in Plasma) [ Time Frame: up to 96 hours after start of treatment ]
  13. Number of patients with adverse events [ Time Frame: up to 53 days ]


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Ages Eligible for Study:   18 Years to 50 Years   (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), 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 (including BP, PR 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
  • 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 (e.g. HIV)
  • History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  • Intake of drugs with a long half-life (> 24 hours) within at least one month or less than five 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 (especially unspecific inducing agents like St.John´s wort (Hypericum perforatum) or drugs which prolong the QT/QTc interval 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) or inability to stop alcoholic beverages for 24 hours prior to dosing and up to the last sampling time point
  • 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 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)

Exclusion criteria specific for this study:

  • Galactose intolerance
  • Lactase deficiency
  • Glucose-galactose-malabsorption

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183441     History of Changes
Other Study ID Numbers: 1218.31
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
Ritonavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors