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
  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:


Further study details as provided by Boehringer Ingelheim:

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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
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 April 17, 2014