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Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01505491
Recruitment Status : Completed
First Posted : January 6, 2012
Last Update Posted : December 13, 2012
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: adalimumab Drug: BI695501 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Safety of BI 695501 in Healthy Subjects: a Randomized, Open-label, Single Dose, Parallel Arm, Active Comparator Clinical Phase I Study
Study Start Date : December 2011
Primary Completion Date : July 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: BI 695501
Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing BI 695501
Drug: BI695501
BI 695501 single s.c injection
Active Comparator: adalimumab - US
Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab
Drug: adalimumab
40mg adalimumab single s.c. injection
Active Comparator: adalimumab - EU
Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab
Drug: adalimumab
40mg adalimumab single s.c. injection



Primary Outcome Measures :
  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity [ Time Frame: 72 days ]
  2. Maximum measured concentration of the analyte in plasma [ Time Frame: 72 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 14 [ Time Frame: 72 days ]
  3. Terminal phase half life [ Time Frame: 72 days ]
  4. Apparent clearance of the analyte in the plasma after extravascular administration [ Time Frame: 72 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505491


Locations
New Zealand
1297.1.002 Boehringer Ingelheim Investigational Site
Auckland, New Zealand
1297.1.001 Boehringer Ingelheim Investigational Site
Christchurch, New Zealand
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01505491     History of Changes
Other Study ID Numbers: 1297.1
First Posted: January 6, 2012    Key Record Dates
Last Update Posted: December 13, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents