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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 Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01505491
First received: January 4, 2012
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: adalimumab
Drug: BI695501
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 193
Study Start Date: December 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01505491     History of Changes
Other Study ID Numbers: 1297.1
Study First Received: January 4, 2012
Last Updated: December 12, 2012
Health Authority: New Zealand: Medsafe

Additional relevant MeSH terms:
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013