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Single and Multiple Dose Evaluation of ABT-072 and to Evaluate the Effect of Food on the Pharmacokinetics of ABT-072

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00982826
First received: September 22, 2009
Last updated: October 19, 2010
Last verified: September 2010
History of Changes
  Purpose

To assess the safety, tolerability and pharmacokinetics of the ABT-072 tablet formulation administered as a single dose and then administered as multiple doses for 7 days. The effect of food on the safety, tolerability and pharmacokinetics of the ABT-072 tablet will also be evaluated.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Blinded, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single and Multiple Doses (7 Days) of ABT-072 and an Open-label Study to Evaluate the Effect of Food on the Pharmacokinetic

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • To determine the single and multiple dose safety and tolerability of the ABT-072 tablet formulation under non-fasting conditions. [ Time Frame: Up to 14 days post last dose. ] [ Designated as safety issue: Yes ]
  • To determine the single and multiple dose safety pharmacokinetics of the ABT-072 tablet formulation under non-fasting conditions. [ Time Frame: 72 hours post last dose. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the effect of food on the pharmacokinetics of the ABT-072 tablet formulation. [ Time Frame: 72 hours post last dose. ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: September 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ABT-072 tablet single ascending dose
 Drug: ABT-072
See Arms information for a detailed description.
Other Name: ABT-072
Experimental: 2
Placebo tablet
 Drug: Placebo
See Arms information for a detailed description.
Other Name: Placebo
Experimental: 3
ABT-072 tablet administered under non-fasting conditions.
 Drug: ABT-072
See Arms information for a detailed description.
Other Name: ABT-072
Experimental: 4
ABT-072 tablet administered under fasting conditions
 Drug: ABT-072
See Arms information for a detailed description.
Other Name: ABT-072
Experimental: 5
ABT-072 tablet multiple ascending dose
 Drug: ABT-072
See Arms information for a detailed description.
Other Name: ABT-072

Detailed Description:

The study consists of two substudies. Substudy 1 is a two-period, single ascending dose (SAD) and multiple ascending dose (MAD) blinded, randomized, placebo-controlled, non-fasting study. Designated groups that participate in Period 1 (SAD) will also participate in Period 2 (MAD). Substudy 2 is an open-label, randomized two-period, crossover study to examine the effect of food on the pharmacokinetics of ABT 072.

  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: NCT00982826

Locations
United States, Illinois
Site Reference ID/Investigator# 23742
Waukegan, Illinois, United States, 60085
Sponsors and Collaborators
Abbott
Investigators
Study Director: Daniel Cohen Abbott
  More Information

No publications provided

Responsible Party: Barry Bernstein, Project Director, Abbott
ClinicalTrials.gov Identifier: NCT00982826     History of Changes
Other Study ID Numbers: M11-057
Study First Received: September 22, 2009
Last Updated: October 19, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Phase 1
Single and Multiple Ascending Dose
Food Effect

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 19, 2013