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NCT Number: NCT00982826

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

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 23742

Waukegan, Illinois, 60085, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABT-072

Drug

See Arms information for a detailed description.

Placebo

Drug

See Arms information for a detailed description.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. To assess the effect of food on the pharmacokinetics of the ABT-072 tablet formulation.

    Time frame: 72 hours post last dose.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Sep 23, 2009
Registry last updated
Oct 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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