Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01505491
Recruitment Status : Completed
First Posted : January 6, 2012
Results First Posted : February 20, 2019
Last Update Posted : February 20, 2019
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

Layout table for study information
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
Actual Study Start Date : December 1, 2011
Actual Primary Completion Date : July 1, 2012
Actual Study Completion Date : July 1, 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

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 BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) [ Time Frame: 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration ]
    Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic.

  2. Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) [ Time Frame: 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration ]
    Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic.

  3. Maximum Measured Concentration of the BI 695501 in Plasma (Cmax) [ Time Frame: 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration ]
    Maximum measured concentration of the BI 695501 in plasma (Cmax). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic.


Secondary Outcome Measures :
  1. Terminal Half- Life of the BI 695501 in Plasma (t1/2) [ Time Frame: 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration ]
    Terminal half- life of the BI 695501 in plasma (t1/2).

  2. Apparent Clearance of the BI 695501 in the Plasma After Extra-vascular Administration (CL/F) [ Time Frame: 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration ]
    Apparent clearance of the BI 695501 in the plasma after extra-vascular administration (CL/F).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location information
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
Layout table for investigator information
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Additional Information:
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01505491    
Other Study ID Numbers: 1297.1
First Posted: January 6, 2012    Key Record Dates
Results First Posted: February 20, 2019
Last Update Posted: February 20, 2019
Last Verified: October 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents