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A Study of Administration of RoActemra/Actemra (Tocilizumab) by Auto-injector Vs. Pre-filled Syringe in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01418989
First received: August 16, 2011
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra (tocilizumab) administration by auto-injector versus pre-filled syringe in healthy volunteers. Healthy volunteers will receive a single dose of RoActemra/Actemra (tocilizumab). The anticipated time of study duration is 28 days.


Condition Intervention Phase
Healthy Volunteer
 Drug: tocilizumab [RoActemra/Actemra] auto-injector
Drug: tocilizumab [RoActemra/Actemra] Syringe
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center Study to Compare the Relative Bioavailability of Tocilizumab in Healthy Subjects Following Single Dose Subcutaneous (SC) Administration Via Disposable Auto-Injector (DAI) Device vs Pre-filled Glass Syringe (PFS)

Resource links provided by NLM:

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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) of RoActemra/Actemra [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Peak plasma concentration of RoActemra/Actemra [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety (Incidence of adverse events) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 239
Study Start Date: July 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra] auto-injector
Single dose administration with auto-injector
Experimental: 2 Drug: tocilizumab [RoActemra/Actemra] Syringe
Single dose administration with pre-filled syringe

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers, age 18 to 65 years inclusive
  • Intact normal skin without potentially obscuring tattoos, pigmentation, lesion in the area for intended injection
  • A body mass index (BMI) between 18 to 32 kg/m2 inclusive

Exclusion Criteria:

  • Volunteers with any known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
  • A history of clinically significant gastrointestinal, renal, hepatic, cardiovascular, or allergic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418989

Locations
France
Montpellier, France, 34094
Rennes, France, 35042
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01418989     History of Changes
Other Study ID Numbers: NP25539
Study First Received: August 16, 2011
Last Updated: May 23, 2013
Health Authority: France: Ministry of Health

ClinicalTrials.gov processed this record on May 23, 2013