Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Relative Bioavailability of Different Formulations of BI 671800 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: NCT02221388
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To compare the oral bioavailability and rate of absorption of two different formulations of BI 671800 HEA (choline salt) tablets 200 mg, one with enteric coating (EC) and one without EC, versus 2 x 100 mg BI 671800 ED (ethylenediamine salt) capsules. Both BI 671800 HEA formulations were further investigated concerning food effect and one of the two BI 671800 HEA formulations identified by interim pharmacokinetic analysis was further investigated concerning dose proportionality with 50 mg.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 671800 HEA, 200 mg tablets Drug: BI 671800 HEA EC, 200 mg tablets Drug: BI 671800 HEA, 50 mg tablets Drug: BI 671800 ED, 100 mg capsules Other: Standard meal Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability of Different Salt Forms and Formulations of Single Doses Either 50 or 200 mg BI 671800 in the Fasted or Fed State. An Open-label, Randomised, Phase I Study With a 3-period Crossover Followed by Two Treatment Periods in Fixed Sequence in Healthy Male and Female Volunteers
Study Start Date : February 2010
Actual Primary Completion Date : July 2010

Arm Intervention/treatment
Active Comparator: BI 671800 ED capsules Drug: BI 671800 ED, 100 mg capsules
Experimental: BI 671800 HEA tablet in fasted state Drug: BI 671800 HEA, 200 mg tablets
Experimental: BI 671800 HEA EC tablet in fasted state Drug: BI 671800 HEA EC, 200 mg tablets
Experimental: BI 671800 HEA tablet in fed state Drug: BI 671800 HEA, 200 mg tablets
Other: Standard meal
Experimental: BI 671800 HEA EC tablet in fed state Drug: BI 671800 HEA EC, 200 mg tablets
Other: Standard meal
Experimental: BI 671800 HEA, 50 mg tablet in fasted state Drug: BI 671800 HEA, 50 mg tablets



Primary Outcome Measures :
  1. Cmax (maximum measured concentration of BI 671800 in plasma) [ Time Frame: Up to 24 hours after last drug administration ]
  2. AUC0-∞ (area under the concentration time curve of BI 671800 in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 24 hours after last drug administration ]

Secondary Outcome Measures :
  1. tmax (time from dosing to the maximum concentration of BI 671800 in plasma) [ Time Frame: Up to 24 hours after last drug administration ]
  2. AUC0-tz (area under the concentration-time curve of BI 671800 in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: Up to 24 hours after drug administration ]
  3. λz (terminal rate constant in plasma) [ Time Frame: Up to 24 hours after drug adminnistration ]
  4. t½ (terminal half-life of BI 671800 in plasma) [ Time Frame: Up to 24 hours after drug administration ]
  5. MRTpo (mean residence time of BI 671800 in the body after po administration) [ Time Frame: Up to 24 hours after drug administration ]
  6. CL/F (apparent clearance of BI 671800 in the plasma after extravascular administration) [ Time Frame: Up to 24 hours after drug administration ]
  7. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: Up to 24 hours after drug administration ]
  8. Number of patients with clinical significant findings in physical examinations [ Time Frame: Up to 10 days after last drug admininstration ]
  9. Number of patients with clinical significant findings in vital signs [ Time Frame: Up to 10 days after last drug administration ]
  10. Number of patients with clinical significant findings in ECG [ Time Frame: Up to 10 days after last drug administration ]
  11. Number of patients with clinical significant findings in laboratory tests [ Time Frame: Up to 10 days after last drug administration ]
  12. Number of patients with adverse events [ Time Frame: Up to 10 days after last drug administration ]
  13. Investigator assessed tolerability on a 4 point scale [ Time Frame: Up to 10 days after last drug administration ]


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.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females according to the following criteria: Based upon a complete medical history, including physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
  • Age 21 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 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 or hypersensitivity (including allergy to drug or its excipients)
  • Intake of drugs within one month or less than 10 half-lives of the respective drug prior to first study drug administration
  • Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
  • Smoker (more than 10 cigarettes or 3 cigars or 3 pipes daily)
  • Alcohol abuse (average consumption of more than 20 g/day in females and 30 g/day in males)
  • Drug abuse
  • Blood donation (more than 100 mL within four weeks prior to day 1 of visit 2)
  • Any laboratory value outside the reference range that is of clinical relevance, especially repeated alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), alkaline phosphatase (ALP) or total bilirubin above upper limit of normal (ULN) at screening and not resolved before dosing.
  • Inability to comply with dietary regimen of trial site
  • Unwilling to avoid excessive sunlight exposure
  • Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval within 10 days prior to administration or during the trial, and CYP2C8 substrates such as amiodarone, amodiaquine, paclitaxel, rosiglitazone, pioglitazone and repaglinide or CYP2C9 such as warfarin, tolbutamide, phenytoin, losartan, acenocoumarol within 1 month or six half lives (whichever is greater).
  • A marked baseline prolongation of the QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
  • A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)

For female subjects of childbearing potential only:

  • Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 2 months after study completion
  • No adequate contraception during the study including three months before first dosing until 2 month after study completion, e.g. not any of the following: implants, injectables, combined hormonal contraceptives, intrauterine device, or surgical sterilisation (including hysterectomy). In addition to this, also a barrier method (e.g. condom) will be required, if the female is not surgically sterilised.
  • Lactation
Additional Information:
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02221388    
Other Study ID Numbers: 1268.56
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014