Phase 1 BA Study, Single Center With Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00870948
First received: March 26, 2009
Last updated: November 4, 2010
Last verified: September 2010
  Purpose

Single dose in healthy volunteers to assess bioavailability (amount of study drug in the system) between different formulations of ABT-874.


Condition Intervention Phase
Healthy
Drug: ABT-874
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Bioavailability following single dose [ Time Frame: Hours: 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 1008, 1344 for Regimens A, C, D and additional hours 4 & 8 for Regimen B and hours 0.5 and 6 hours for Regimen E ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study [ Time Frame: Through Day 85 (and / or 45 days after study drug stoppped) ] [ Designated as safety issue: Yes ]

Enrollment: 75
Study Start Date: January 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regimen A
One 100 mg ABT-874 (pre-filled syringe liquid formulation from the 6000 L process) injected subcutaneously in the abdominal region at a 45 degree angle
Drug: ABT-874
See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.
Other Name: ABT-874
Experimental: Regimen B
One 100 mg ABT-874 (pre-filled syringe liquid formulation from the 6000 L process) injected IV in an arm vein
Drug: ABT-874
See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.
Other Name: ABT-874
Experimental: Regimen C
One 100 mg ABT 874 (reconstituted lyophilized powder from the 3000 L process) injected subcutaneously in the abdominal region at a 45 degree angle
Drug: ABT-874
See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.
Other Name: ABT-874
Experimental: Regimen D
One 100 mg ABT-874 (reconstituted lyophilized powder from the 1000 L process) injected subcutaneously in the abdominal region at a 45 degree angle
Drug: ABT-874
See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.
Other Name: ABT-874
Experimental: Regimen E
700 mg ABT-874 (reconstituted lyophilized powder from the 3000 L process) in 100 mL 5% dextrose solution IV infusion in an arm vein
Drug: ABT-874
See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.
Other Name: ABT-874

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must be healthy

Exclusion Criteria:

  • Subjects who are not healthy, enrolled in another study, or who have received ABT-874 previously.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00870948

Locations
United States, Indiana
Site Reference ID/Investigator # 16001
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Abbott
Investigators
Study Director: Joaquin Valdes, MD Abbott
  More Information

No publications provided

Responsible Party: Joaquin Valdes, MD, Abbott
ClinicalTrials.gov Identifier: NCT00870948     History of Changes
Other Study ID Numbers: M10-220
Study First Received: March 26, 2009
Last Updated: November 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Open Label
Healthy Volunteers

ClinicalTrials.gov processed this record on April 23, 2014