Phase 1 BA Study, Single Center With Healthy Volunteers

NCT ID: NCT00870948

Last Updated: 2010-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Keywords

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Open Label Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

ABT-874

Intervention Type DRUG

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

Regimen B

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

Group Type EXPERIMENTAL

ABT-874

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

ABT-874

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

ABT-874

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

ABT-874

Intervention Type DRUG

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

Interventions

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ABT-874

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must be healthy

Exclusion Criteria

* Subjects who are not healthy, enrolled in another study, or who have received ABT-874 previously.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Principal Investigators

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Joaquin Valdes, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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Site Reference ID/Investigator # 16001

Evansville, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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M10-220

Identifier Type: -

Identifier Source: org_study_id