Evaluation of the Bioavailability of Two ABT-072 Tablet Formulations as Compared to ABT-072 Capsule Formulation
An Open-Label, Randomized, Crossover Study to Evaluate the Bioavailability of Two Candidate Tablet Formulations of ABT-072 With Reference to the Capsule Formulation
1 other identifier
interventional
18
1 country
1
Brief Summary
The purpose of this study is to assess the bioavailability, safety, tolerability and pharmacokinetics of two tablet formulations as compared to the capsule formulation suspended in liquid.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 24, 2009
CompletedFirst Posted
Study publicly available on registry
July 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedOctober 21, 2010
September 1, 2010
1 month
July 24, 2009
October 19, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the relative bioavailability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.
4 days post each dose
Secondary Outcomes (1)
To evaluate safety and tolerability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.
Through 14 days post last dose.
Study Arms (2)
Tablet 1 vs. Capsule
ACTIVE COMPARATORSingle dose of 2 x 50 mg tablets (Tablet 1) vs. 100 mg ABT-072 (contents of capsules) suspended in liquid.
Tablet 2 vs. Capsule
ACTIVE COMPARATORSingle dose of 2 x 50 mg tablets (Tablet 2) vs. 100 mg ABT-072 (contents from capsules) suspended in liquid.
Interventions
Eligibility Criteria
You may qualify if:
- Overall healthy subjects, non-childbearing females included.
You may not qualify if:
- Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer.
- Pregnant or breast-feeding female.
- Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab).
- Positive screen for drugs of abuse, alcohol, or cotinine.
- Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder.
- Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (1)
Site Reference ID/Investigator# 22384
Waukegan, Illinois, 60085, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Daniel Cohen, MD
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 24, 2009
First Posted
July 28, 2009
Study Start
July 1, 2009
Primary Completion
August 1, 2009
Last Updated
October 21, 2010
Record last verified: 2010-09