NCT00870948

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Last Updated

November 8, 2010

Status Verified

September 1, 2010

Enrollment Period

3 months

First QC Date

March 26, 2009

Last Update Submit

November 4, 2010

Conditions

Healthy

Keywords

Open LabelHealthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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)

Study Arms (5)

Regimen A

EXPERIMENTAL

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

Regimen B

EXPERIMENTAL

One 100 mg ABT-874 (pre-filled syringe liquid formulation from the 6000 L process) injected IV in an arm vein

Drug: ABT-874

Regimen C

EXPERIMENTAL

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

Regimen D

EXPERIMENTAL

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

Regimen E

EXPERIMENTAL

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

Interventions

ABT-874DRUG

See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.

Regimen ARegimen BRegimen CRegimen DRegimen E

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects must be healthy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site Reference ID/Investigator # 16001

Evansville, Indiana, 47710, United States

Location

MeSH Terms

Interventions

briakinumab

Study Officials

  • Joaquin Valdes, MD

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 27, 2009

Study Start

January 1, 2009

Primary Completion

April 1, 2009

Last Updated

November 8, 2010

Record last verified: 2010-09

Locations

US(1)