Trial record 1 of 1 for:    NCT01505491
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Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01505491
First received: January 4, 2012
Last updated: December 12, 2012
Last verified: December 2012

January 4, 2012
December 12, 2012
December 2011
July 2012   (final data collection date for primary outcome measure)
  • Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity [ Time Frame: 72 days ] [ Designated as safety issue: No ]
  • Maximum measured concentration of the analyte in plasma [ Time Frame: 72 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01505491 on ClinicalTrials.gov Archive Site
  • 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: 72 days ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 14 [ Time Frame: 72 days ] [ Designated as safety issue: No ]
  • Terminal phase half life [ Time Frame: 72 days ] [ Designated as safety issue: No ]
  • Apparent clearance of the analyte in the plasma after extravascular administration [ Time Frame: 72 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects
Pharmacokinetics and Safety of BI 695501 in Healthy Subjects: a Randomized, Open-label, Single Dose, Parallel Arm, Active Comparator Clinical Phase I Study

This trial will investigate the pharmacokinetics, safety and tolerability of BI 695501 and to establish pharmacokinetic equivalence of BI 695501 to adalimumab.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: adalimumab
    40mg adalimumab single s.c. injection
  • Drug: BI695501
    BI 695501 single s.c injection
  • Experimental: BI 695501
    Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing BI 695501
    Intervention: Drug: BI695501
  • Active Comparator: adalimumab - US
    Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab
    Intervention: Drug: adalimumab
  • Active Comparator: adalimumab - EU
    Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab
    Intervention: Drug: adalimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
193
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Healthy males
  2. Body mass index (BMI) =18.5 to =29.9 kg/m2

Exclusion criteria:

  1. Any clinically relevant abnormal finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
  2. Any evidence of a clinically relevant previous or concomitant disease as judged by the investigator.
  3. Chronic or relevant acute infections. A negative result for Human Immunodeficiency Virus, Hepatitis B and Hepatitis C testing is required for participation.
  4. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  5. Intake of prescribed or over-the-counter drugs with a long half-life (>24 hours) within at least one month or less than 5 half-lives of the respective drug prior to administration or during the trial
  6. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
  7. Inability to refrain from smoking during days of confinement at the study center
  8. Alcohol abuse (average more than 30 g/day)
  9. Current drug abuse
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
NCT01505491
1297.1
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
December 2012

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