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
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, see Learn About Clinical Studies.

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 July 28, 2014