Phase 1 BA Study, Single Center With Healthy Volunteers
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00870948
First received: March 26, 2009
Last updated: November 4, 2010
Last verified: September 2010
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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 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 May 16, 2013