Safety and Pharmacokinetics of Multiple Rising Oral Doses of BI 224436 in Healthy Male Volunteers.

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01276990
First received: January 13, 2011
Last updated: February 8, 2012
Last verified: February 2012

January 13, 2011
February 8, 2012
January 2011
September 2012   (final data collection date for primary outcome measure)
  • Changes in blood pressure [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Changes in pulse rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Changes in 12-lead ECG [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Changes in clinical laboratory test parameters [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01276990 on ClinicalTrials.gov Archive Site
  • Cmax,ss (maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval t) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady-state) [ Time Frame: 10 Days ] [ Designated as safety issue: No ]
  • Cmin,ss (minimum concentration of the analyte in plasma at steady-state over a uniform dosing interval t) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval t) [ Time Frame: 13 days ] [ Designated as safety issue: No ]
  • t1/2,ss (terminal half-life of the analyte in plasma at steady-state) [ Time Frame: 13 days ] [ Designated as safety issue: No ]
  • CL/F,ss (apparent clearance of the analyte in the plasma at steady-state following extravascular multiple dose administration) [ Time Frame: 13 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Pharmacokinetics of Multiple Rising Oral Doses of BI 224436 in Healthy Male Volunteers.
Safety and Pharmacokinetics of Multiple Rising Oral Doses of BI 224436 ZW (Powder in Bottle Formulation) at 12.5 mg q24h, 12.5 mg q12h, 12.5 mg q8h, 25 mg q12h, 25 mg q8h, 50 mg q12h, 37.5 mg q8h and 50 mg q8h Dose Levels for 10 Days in Healthy Male Volunteers (Randomized, Double-blind Placebo-controlled Within Dose Groups)

To investigate the safety and pharmacokinetic of BI 224436 in healthy male volunteers following oral administration of repeated doses for 10 days within 8 dosing regimens.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • HIV Infections
  • Healthy
  • Drug: BI 224436
    Oral drinking solution
  • Drug: Placebo
    Oral drinking solution
  • Placebo Comparator: Placebo
    Matching placebo in dosing regimen 1-8
    Interventions:
    • Drug: BI 224436
    • Drug: Placebo
  • Experimental: BI 224436 dosing regimen 1
    Dosing regimen 1
    Intervention: Drug: BI 224436
  • Experimental: BI 224436 dosing regimen 2
    Dosing regimen 2
    Intervention: Drug: BI 224436
  • Experimental: BI 224436 dosing regimen 3
    Dosing regimen 3
    Intervention: Drug: BI 224436
  • Experimental: BI 224436 dosing regimen 4
    Dosing regimen 4
    Intervention: Drug: BI 224436
  • Experimental: BI 224436 dosing regimen 5
    Dosing regimen 5
    Intervention: Drug: BI 224436
  • Experimental: BI 224436 dosing regimen 6
    Dosing regimen 6
    Intervention: Drug: BI 224436
  • Experimental: BI 224436 dosing regimen 7
    Dosing regimen 7
    Intervention: Drug: BI 224436
  • Experimental: BI 224436 dosing regimen 8
    Dosing regimen 8
    Intervention: Drug: BI 224436
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
September 2012   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Healthy male 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.
  2. Age >=18 and <=50 years.
  3. Body Mass Index (BMI) >=18.5 and BMI <=32 kg/m2.
  4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation.
  5. Documented to be sterile; or, if can father a child, agree to abstain from sexual intercourse during and at least seven days following last study drug administration, or are willing to use condoms during the same period each time (Subject's female sexual partner(s) of child-bearing potential should be willing to use either ethinyl estradiol containing oral contraceptives or a reliable barrier method of contraception).

Exclusion criteria:

  1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance according to the opinion of the investigator.
  2. Any evidence of a clinically relevant concomitant disease.
  3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
  4. Surgery of the gastrointestinal tract that in the opinion of the investigator may affect the absorption.
  5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
  6. History of relevant orthostatic hypotension, fainting spells or blackouts.
  7. History or evidence of Human Immunodeficiency Virus or other chronic or relevant acute infections, including Hepatitis C Virus and Hepatitis B Virus infection.
  8. History of relevant allergy / hypersensitivity (including allergy to investigational medicinal product or its solvent).
  9. History of any familial skeletal muscle disorder, or history of Creatine Kinase (CK) elevation not due to strenuous physical activity or trauma.
  10. 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.
  11. Use of drugs, including prescription and non-prescription drugs, and St. Johns Wort which might reasonably influence the results of the trial within 14 days prior to study drug administration or during the trial, or consumption of grapefruit, grapefruit juice, orange juice, Seville oranges, green tea, pineapple, pineapple juice, broccoli or red wine within 3 days prior study drug administration or during the trial.
  12. Participation in another trial with an investigational drug within one month prior to administration or during the trial.
  13. Current smoker (>10 cigarettes or >3 cigars or >3 pipes / day).
  14. Inability to refrain from smoking during the trial.
  15. Alcohol abuse (more than 30 g day).
  16. Drug abuse.
  17. Blood donation (more than 100 mL within four weeks prior to administration or during the trial).
  18. Physical activity in excess of usual activity of daily living (e.g., fitness physical exercise, physical labor) within 7 days prior to study drug administration until end of study visit.
  19. Any laboratory value outside the reference range that in the opinion of the investigator is of clinical relevance.
  20. A marked baseline prolongation of QT or corrected QT (QTc) intervals (e.g., repeated demonstration of a QTc interval >450 ms); or, other ECG abnormality of clinical significance.
  21. A history of additional risk factors for Torsades de points (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
  22. CK at screening =2x Upper Limit of Normal (ULN) (If CK is =2xULN and <5xULN one retest will be allowed to verify the result).
  23. CK at baseline (Day -1) >ULN (If CK is >ULN and <1.5xULN one retest will be allowed to verify the result).
  24. Thyroid - stimulating hormone outside normal reference range, or history of hypo-or hyperthyroidism.
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01276990
1277.2
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP