Phase 1 BA Study, Single Center With Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ABT-874

• Registration Number: NCT00870948
• Lead Sponsor: Abbott

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-27
• Primary Completion: 2009-04
• Status Verified: 2010-09
• Last Update Submitted: 2010-11-04
• Last Update Posted: 2010-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Subjects must be healthy

Exclusion Criteria

• Subjects who are not healthy, enrolled in another study, or who have received ABT-874 previously.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regimen A	ABT-874	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
Regimen B	ABT-874	One 100 mg ABT-874 (pre-filled syringe liquid formulation from the 6000 L process) injected IV in an arm vein
Regimen C	ABT-874	One 100 mg ABT 874 (reconstituted lyophilized powder from the 3000 L process) injected subcutaneously in the abdominal region at a 45 degree angle
Regimen E	ABT-874	700 mg ABT-874 (reconstituted lyophilized powder from the 3000 L process) in 100 mL 5% dextrose solution IV infusion in an arm vein
Regimen D	ABT-874	One 100 mg ABT-874 (reconstituted lyophilized powder from the 1000 L process) injected subcutaneously in the abdominal region at a 45 degree angle

Primary Outcome Measures

Name	Time	Method
Bioavailability following single dose	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

Name	Time	Method
AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study	Through Day 85 (and / or 45 days after study drug stoppped)

Trial Locations

Locations (1)

Site Reference ID/Investigator # 16001; 🇺🇸 Evansville, Indiana, United States