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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014