ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 186 for:    BI10773

BI 10773 Administered as Oral Solution to Healthy Male 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: NCT02172274
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to determine the pharmacokinetics of BI 10773 and total radioactivity including excretion mass balance, excretion pathways and metabolism following the oral administration of [14C] BI 10773

Condition or disease Intervention/treatment Phase
Healthy Drug: [14C]-BI 10773 - oral solution Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Single-dose Trial to Investigate the Metabolism and Pharmacokinetics of 50 mg [14C]-BI 10773 When Administered as Oral Solution to Healthy Male Volunteers
Study Start Date : June 2008
Actual Primary Completion Date : July 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: [14C]-BI 10773 - oral solution Drug: [14C]-BI 10773 - oral solution



Primary Outcome Measures :
  1. Cmax (maximum concentration of the analyte in plasma) [ Time Frame: pre-dose and up to 144 hours after administration ]
  2. tmax (time from dosing to the maximum concentration of the analyte in plasma) [ Time Frame: pre-dose and up to 144 hours after administration ]
  3. 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: pre-dose and up to 144 hours after administration ]
  4. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity) [ Time Frame: pre-dose and up to 144 hours after administration ]
  5. λz (terminal rate constant in plasma) [ Time Frame: pre-dose and up to 144 hours after administration ]
  6. t1/2 (terminal half-life of the analyte(s) in plasma) [ Time Frame: pre-dose and up to 144 hours after administration ]
  7. MRTpo (mean residence time of the analyte(s) in the body after oral administration) [ Time Frame: pre-dose and up to 144 hours after administration ]
  8. CL/F (apparent/total clearance of the analyte(s) in plasma after an extravascular dose) [ Time Frame: pre-dose and up to 144 hours after administration ]
  9. Vz/F (apparent volume of distribution during the terminal phase λz after an extravascular dose) [ Time Frame: pre-dose and up to 144 hours after administration ]
  10. feurine,0-tz (amount of analyte excreted in urine over the time interval from 0 to the time of the last quantifiable data point in % of dose, additionally excretion within each sampling interval will be calculated) [ Time Frame: pre-dose and up to 168 hours after administration ]
  11. fefaeces,0-tz (amount of analyte excreted in faeces over the time interval from 0 to the time of the last quantifiable data point in % of dose, additionally excretion within each sampling interval will be calculated) [ Time Frame: pre-dose and up to 168 hours after administration ]
  12. CLR,0-tz (renal clearance of analyte) [ Time Frame: pre-dose and up to 168 hours after administration ]
  13. Individual concentration-time profiles of [14C] radioactivity in whole blood, plasma, urine, and faeces [ Time Frame: up to 8 days ]
  14. Individual concentration-time profiles of BI 10773 in plasma and urine [ Time Frame: up to 8 days ]
  15. Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces [ Time Frame: up to 8 days ]
  16. Identification of major metabolites in urine, faeces, and plasma [ Time Frame: up to 8 days ]
  17. Cblood cell/Cplasma ratio of [14C]-radioactivity [ Time Frame: up to 8 days ]
  18. Measurement of the plasma protein binding of total [14C] radioactivity in human plasma samples ex vivo [ Time Frame: up to 8 days ]

Secondary Outcome Measures :
  1. Number of patients with abnormal findings in physical examination [ Time Frame: Baseline and within 6 days after discharge ]
  2. Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate) [ Time Frame: Baseline, days 1, 2, 7 and within 6 days after discharge ]
  3. Number of patients with abnormal findings in 12-lead electrocardiogram (ECG) [ Time Frame: Baseline, days 1, 2, 7 and within 6 days after discharge ]
  4. Number of patients with abnormal changes in laboratory parameters [ Time Frame: Baseline, days 1, 2 and within 6 days after discharge ]
  5. Number of patients with adverse events [ Time Frame: Up to 22 days ]
  6. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: Day 8 ]


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 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males according to a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG (electrocardiogram), and clinical laboratory tests
  • Age 18 to 55 years, inclusive
  • Body mass index 18.5 to 29.9 kg/m2, inclusive
  • Nonsmoker
  • 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 in the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
  • Any evidence of a clinically relevant concomitant disease
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal, psychiatric or neurological disorders (including all forms of epilepsy)
  • Surgery of the gastrointestinal tract (except appendectomy)
  • History of relevant orthostatic hypotension, fainting spells or blackouts
  • Subjects with Gilbert's Syndrome
  • 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 (>24 hours) within one month prior to administration of the trial drug
  • Use of prescription medication, over-the-counter drugs or herbal preparations within 14 days prior to administration of the trial drug
  • Participation in another trial with an investigational drug within two months prior to administration of the trial drug or during the trial
  • History or evidence of habitual tobacco or nicotine use within six months prior to administration of the trial drug
  • Alcohol abuse (more than 60 g/day)
  • Drug abuse in opinion of investigator
  • Blood donation (more than 100 mL within four weeks prior to administration of trial drug or during the trial)
  • Excessive physical activity within five days prior to administration of trial drug
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of trial centre
  • A marked baseline prolongation of QT/QTc interval (corrected QT interval)(e.g., repeated demonstration of a QTc interval >450 ms)
  • Male subjects must agree to minimise the risk of female partners becoming pregnant from the dosing day until three months after the completion of the study. Acceptable methods of contraception for male volunteers include a vasectomy no less than three months prior to dosing, barrier contraception, or a medically accepted contraceptive method. For female partners of male volunteers, acceptable methods of contraception include intrauterine device, tubal ligation, hormonal contraceptive for at least two months, or diaphragm with spermicide
  • Participation in more than one other radiolabeled investigational drug trial within one year prior to administration of the trial drug. The previous radiolabeled trial drug must have been received more than six months prior to administration of the trial drug for this study, and the total exposure from this study and the previous study will be within the recommended levels considered safe, per 21 CFR (Code of Federal Regulations) 361.1 (eg, less than 5000 mrem whole body annual exposure)
  • Irregular defecation pattern (less than one bowel movement a day)

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02172274     History of Changes
Other Study ID Numbers: 1245.8
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014

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