Assess the Oral Bioavailability of New ABT-263 Formulations

NCT00743028 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2010-10-07

No results posted yet for this study

Summary

This is a randomized, open-label, multicenter crossover study to determine the oral bioavailability of new ABT-263 formulations relative to that of the current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Approximately 36 evaluable subjects with lymphoid malignancies, including chronic lymphocytic leukemia, and solid tumors will be enrolled in this study.

Conditions

Interventions

DRUG

ABT-263

Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2 studies vs. a single dose of one of the new ABT-263 formulation

DRUG

ABT-263

Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies vs. a single dose of a new ABT-263 formulation followed by QD dosing with a new ABT-263 formulation for 7 days.

DRUG

ABT-263

Single dose of the current ABT-263 formulation being assessed in ongoing Phase 1/2a studies vs. a single dose of a new ABT-263 formulation followed by QD dosing with a new ABT-263 formulation for 7 days.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY
  • Abbott

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-08-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00743028 on ClinicalTrials.gov