Phase 1 BA Study, Single Center With Healthy Volunteers

Abbott

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ABT-874

Study type: Interventional

Funder types: Industry

Identifiers

NCT00870948

M10-220

Details and patient eligibility

About

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

Enrollment: 75 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects must be healthy

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 5 patient groups

Regimen A

Experimental group

Description:

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

Treatment:

Drug: ABT-874

Regimen B

Experimental group

Description:

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

Treatment:

Drug: ABT-874

Regimen C

Experimental group

Description:

One 100 mg ABT 874 (reconstituted lyophilized powder from the 3000 L process) injected subcutaneously in the abdominal region at a 45 degree angle

Treatment:

Drug: ABT-874

Regimen D

Experimental group

Description:

One 100 mg ABT-874 (reconstituted lyophilized powder from the 1000 L process) injected subcutaneously in the abdominal region at a 45 degree angle

Treatment:

Drug: ABT-874

Regimen E

Experimental group

Description:

700 mg ABT-874 (reconstituted lyophilized powder from the 3000 L process) in 100 mL 5% dextrose solution IV infusion in an arm vein

Treatment:

Drug: ABT-874