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Completed

NCT Number: NCT00890318

A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072 Used to Treat Hepatitis C

The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-072 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.

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Key information

Conditions

HCV Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C 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

Abbott Clinical Pharmaceutical Research Unit

Waukegan, Illinois, 60085, United States

About this study

Phase 1, Blinded, Randomized, Placebo-controlled Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Main Selection Criteria for Healthy Volunteers:
  • Subject has provided written consent.
  • Subject is in general good health.
  • If female, subject is postmenopausal for at least 2 years or surgically sterile.
  • If female, subject is not pregnant and is not breast-feeding.
  • Male or female between 18 and 55 years old, inclusive.
  • If male, subject must be surgically sterile or practicing at least 1 method of birth control.
  • Body Mass Index (BMI) is 18 to 29, inclusive.

Exclusion criteria

  • Use of medications including over the counter and vitamines.
  • Abuse of alcohol, drugs, or nicotine.
  • Current diseases or disorders.
  • History of cardiac disease.
  • If after consideration by the investigator, for any reason, that you are unsuitable to receive ABT-072.

Treatment and study plan

ABT-072

Drug

Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.

ketoconazole

Other

Tablet, see Arm Description for intervention information.

Placebo

Drug

Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.

Primary outcomes

  1. Analysis of pharmacokinetic results.

    Time frame: Study Days 1-13

  2. Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.

    Time frame: Study Days -2 through 39

Secondary outcomes

  1. Analysis of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.

    Time frame: Study Day 11-13

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
First posted
Apr 29, 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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