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Pharmacokinetics Study of NI-071

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: NCT01931189
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : June 30, 2014
Sponsor:
Information provided by (Responsible Party):
Nichi-Iko Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE August 26, 2013
First Posted Date  ICMJE August 29, 2013
Last Update Posted Date June 30, 2014
Study Start Date  ICMJE August 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
PK : Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt) [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
  • PK : Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf) [ Time Frame: 8 weeks ]
  • Safety : Incidence of Adverse Events [ Time Frame: 8 weeks ]
  • Safety : Incidence of Anti-Drug Antibodies(ADA) [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics Study of NI-071
Official Title  ICMJE A Clinical Pharmacokinetics Study of NI-071
Brief Summary The purpose of this study is to assess equivalence of pharmacokinetics between NI-071 and infliximab(the comparator) in Japanese healthy volunteers
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: NI-071
    100mg/vial
  • Biological: Infliximab
    100mg/vial
    Other Name: Remicade
Study Arms  ICMJE
  • Experimental: NI-071
    Intervention: Biological: NI-071
  • Active Comparator: Infliximab
    Intervention: Biological: Infliximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2013)
96
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, clinical laboratory tests, etc.)
  2. Body Mass Index (BMI) of 18.5 to 25.0 kg/m2, and a total body weight of 50 to 80 kg

Exclusion Criteria:

  1. Subjects with a following past History or concomitant diseases

    • Chronic or recurrent infectious disease
    • Demyelinating disease
    • Congestive heart failure
    • lymphoproliferative disorder or myelodysplastic syndrome
    • Malignancy
    • Interstitial lung disease
  2. Subjects with active or latent tuberculosis or history of tuberculosis
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01931189
Other Study ID Numbers  ICMJE NI071A1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nichi-Iko Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Nichi-Iko Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nichi-Iko Pharmaceutical Co., Ltd.
Verification Date June 2014

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