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Evaluation of the Bioavailability of Two ABT-072 Tablet Formulations as Compared to ABT-072 Capsule Formulation

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00947440
First received: July 24, 2009
Last updated: October 19, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatitis C
 Drug: ABT-072
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: An Open-Label, Randomized, Crossover Study to Evaluate the Bioavailability of Two Candidate Tablet Formulations of ABT-072 With Reference to the Capsule Formulation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • To evaluate the relative bioavailability of two candidate tablet formulations of ABT-072 to that of the capsule formulation. [ Time Frame: 4 days post each dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate safety and tolerability of two candidate tablet formulations of ABT-072 to that of the capsule formulation. [ Time Frame: Through 14 days post last dose. ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: July 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tablet 1 vs. Capsule
Single dose of 2 x 50 mg tablets (Tablet 1) vs. 100 mg ABT-072 (contents of capsules) suspended in liquid.
 Drug: ABT-072
See arm description for more information
Other Name: ABT-072
Active Comparator: Tablet 2 vs. Capsule
Single dose of 2 x 50 mg tablets (Tablet 2) vs. 100 mg ABT-072 (contents from capsules) suspended in liquid.
 Drug: ABT-072
See arm description for more information
Other Name: ABT-072

Detailed Description:

A single-dose, three period, complete cross-over study to evaluate the relative bioavailability, pharmacokinetics, safety and tolerability of two candidate tablet formulations of ABT-072 when compared to that of the original capsule formulation suspended in liquid as a reference.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overall healthy subjects, non-childbearing females included.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947440

Locations
United States, Illinois
Site Reference ID/Investigator# 22384
Waukegan, Illinois, United States, 60085
Sponsors and Collaborators
Abbott
Investigators
Study Director: Daniel Cohen, MD Abbott
  More Information

No publications provided

Responsible Party: Daniel Cohen, MD/Study Medical Director, Abbott Laboratories
ClinicalTrials.gov Identifier: NCT00947440     History of Changes
Other Study ID Numbers: M11-056
Study First Received: July 24, 2009
Last Updated: October 19, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Phase 1
Bioavailability

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 16, 2013