ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioavailability of BI 1356 With and Without Co-administration of Pioglitazone and the Bioavailability of Pioglitazone With and Without Coadministration of BI 1356 in Healthy Male and Female Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02183337
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 bioavailability of BI 1356 with and without co-administration of pioglitazone and the bioavailability of pioglitazone with and without coadministration of BI 1356

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability of Both BI 1356 and Pioglitazone After Co-administration Compared to the Bioavailability of Multiple Oral Doses of BI 1356 10 mg qd Alone and Pioglitazone 45 mg qd Alone in Healthy Male and Female Volunteers (an Open Label, Randomised, Multiple-dose, Two-way Crossover Study)
Study Start Date : February 2007
Actual Primary Completion Date : April 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BI 1356

Treatment sequence AB_C or C_AB

  • Treatment A: 5 days BI 1356 until steady state followed by
  • Treatment B: combined treatment of BI 1356 with pioglitazone for 7 days
  • Treatment C: 7 days of treatment with Pioglitazone alone
Drug: BI 1356
Drug: BI 1356 + Pioglitazone
Drug: Pioglitazone
Active Comparator: Pioglitazone

Treatment sequence AB_C or C_AB

  • Treatment A: 5 days BI 1356 until steady state followed by
  • Treatment B: combined treatment of BI 1356 with pioglitazone for 7 days
  • Treatment C: 7 days of treatment with Pioglitazone alone
Drug: BI 1356
Drug: BI 1356 + Pioglitazone
Drug: Pioglitazone



Primary Outcome Measures :
  1. 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 21 days ]
  2. Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: up to 21 days ]

Secondary Outcome Measures :
  1. tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) [ Time Frame: up to 21 days ]
  2. C24,ss (concentration of the analyte in plasma at steady state after administration of the last dose at the end of the dosing interval) [ Time Frame: up to 21 days ]
  3. λz,ss (terminal rate constant in plasma at steady state) [ Time Frame: up to 21 days ]
  4. t1/2,ss (terminal half-life of the analyte in plasma at steady state) [ Time Frame: up to 21 days ]
  5. MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration) [ Time Frame: up to 21 days ]
  6. CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state) [ Time Frame: up to 21 days ]
  7. Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration) [ Time Frame: up to 21 days ]
  8. Changes in physical examination (including body weight) [ Time Frame: up to 27 days after last administration of study medication ]
  9. Changes in Vital signs (Blood pressure (BP), Pulse Rate (PR) [ Time Frame: up to 27 days after last administration of study medication ]
  10. Changes in 12-lead ECG (electrocardiogram) [ Time Frame: up to 27 days after last administration of study medication ]
  11. Changes in clinical laboratory values [ Time Frame: up to 27 days after last administration of study medication ]
  12. Number of patients with adverse events [ Time Frame: up to 27 days after last administration of study medication ]
  13. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: up to 27 days after last administration of study medication ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy females and 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 ≤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, 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 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 or that 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)
  • 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 Torsade de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

For male subjects:

  • Not willing to use adequate contraception (condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, IUD [intrauterine device]) during the whole study period from the time of the first intake of study drug until one month after the last intake

For female subjects:

  • Pregnancy or planning to become pregnant within 2 months of study completion
  • Positive pregnancy test
  • Are not willing or are unable to use a reliable method of contraception (such as implants, injectibles and combined oral contraceptives, sterilisation, IUD, double barrier method) for at least 3 months prior to participation in the trial, during and up to 2 months after completion/termination of the trial
  • Chronic use of oral contraception or hormone replacement containing ethinyl estradiol as the only method of contraception
  • Lactation period

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183337     History of Changes
Other Study ID Numbers: 1218.13
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Pioglitazone
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