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Phase 1 BA Study, Single Center With Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00870948
Recruitment Status : Completed
First Posted : March 27, 2009
Last Update Posted : November 8, 2010
Sponsor:
Information provided by:
Abbott

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

Condition or disease Intervention/treatment Phase
Healthy Drug: ABT-874 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : January 2009
Actual Primary Completion Date : April 2009

Arm Intervention/treatment
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.
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.
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.
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.
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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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.

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): 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

Responsible Party: Joaquin Valdes, MD, Abbott
ClinicalTrials.gov Identifier: NCT00870948     History of Changes
Other Study ID Numbers: M10-220
First Posted: March 27, 2009    Key Record Dates
Last Update Posted: November 8, 2010
Last Verified: September 2010

Keywords provided by Abbott:
Open Label
Healthy Volunteers