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Trial record 35 of 186 for:    BI10773

Bioavailability of BI 10773 and Pioglitazone in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02276365
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The objective of the study was to investigate whether there is a drug-drug interaction between BI 10773 and pioglitazone when co-administered as multiple oral doses. Therefore, the relative bioavailabilities of BI 10773 and pioglitazone were determined when both drugs were given in combination compared with BI 10773 and pioglitazone given alone.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 10773 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 10773 50 mg and Pioglitazone 45 mg After Co-administration Compared to BI 10773 and Pioglitazone Alone in Healthy Male Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study)
Study Start Date : June 2009
Actual Primary Completion Date : July 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequence ABC
  1. Treatment A: 50 mg BI 10773 once daily from day 1 to 5
  2. Treatment B: 50 mg BI 10773 and 45 mg pioglitazone once daily from day 1 to 7
  3. Treatment C: 45 mg pioglitazone once daily from day 1 to 7 after 7 days wash-out
Drug: BI 10773
Drug: Pioglitazone
Experimental: Sequence CAB
  1. Treatment C: 45 mg pioglitazone once daily from day 1 to 7
  2. Treatment A: 50 mg BI 10773 once daily from day 1 to 5 after 7 days wash-out
  3. Treatment B: 50 mg BI 10773 and 45 mg pioglitazone once daily from day 1 to 7
Drug: BI 10773
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 10 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 10 days ]

Secondary Outcome Measures :
  1. Abnormal findings in physical examination [ Time Frame: Baseline and up to 10 days after last study drug administration ]
  2. Changes from baseline in vital signs (Blood pressure, pulse rate) [ Time Frame: Baseline and up to 10 days after last study drug administration ]
  3. Changes from baseline in 12-lead ECG (electrocardiogram) [ Time Frame: Baseline and up to 10 days after last study drug administration ]
  4. Changes in clinical laboratory tests [ Time Frame: Baseline and up to 10 days after last study drug administration ]
  5. Incidence of adverse events [ Time Frame: up to 35 days ]
  6. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: Within 3-10 days after last study drug administration ]
  7. C24,N (concentration of analyte in plasma at 24 hours post-drug administration after administration of the Nth dose) [ Time Frame: up to 10 days ]
  8. λz,ss (terminal half-life of the analyte in plasma) [ Time Frame: up to 10 days ]
  9. t½,ss (terminal half-life of the analyte in plasma at steady state) [ Time Frame: up to 10 days ]
  10. tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: up to 10 days ]
  11. MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration) [ Time Frame: up to 10 days ]
  12. CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state) [ Time Frame: up to 10 days ]
  13. Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration) [ Time Frame: up to 10 days ]
  14. Aet1-t2,ss (amount of analyte eliminated in urine at steady state over a uniform dosing interval τ) [ Time Frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing ]
  15. fet1-t2,ss (fraction of analyte excreted unchanged in urine at steady state over a uniform dosing interval τ) [ Time Frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing ]
  16. CLR,ss (renal clearance of the analyte at steady state) [ Time Frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing ]
  17. UGE0-24 (Urinary glucose excretion of the analyte in urine over the time interval from time zero to 24 h) [ Time Frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing ]


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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 ECG (electrocardiogram), clinical laboratory tests
  • Age 18 to 50 years (incl.)
  • BMI 18.5 to 29.9 kg/m2 (incl.)
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) 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
  • History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  • Intake of drugs with a long half-life (more than 24 hours) within at least one month or less than 10 half-lives of the respective drug 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 (more than 10 cigarettes or more than 3 cigars or more than 3 pipes/day)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (more than 30 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)
  • ALT (Alanine transaminase) outside the normal range or any other laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of trial site
  • Galactose or lactose intolerance, galactose or glucose malabsorption

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02276365     History of Changes
Other Study ID Numbers: 1245.17
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Pioglitazone
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs