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.

Study Overview

• Status: Completed
• Conditions: HCV Infection
• Intervention / Treatment: Drug: ABT-072; Other: ketoconazole; Drug: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Waukegan, Illinois, United States, 60085
      • Abbott Clinical Pharmaceutical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Healthy volunteers, receiving daily dose of 80 mg ABT-072 or placebo, QD for 10 days; and on Study Day 11 receiving a single dose of 80 mg ABT-072 or placebo + 400 mg ketoconazole	Drug: ABT-072; Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.; Other: ketoconazole; Tablet, see Arm Description for intervention information.; Drug: Placebo; Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.
Other: 2; Healthy volunteers, receiving 160 mg ABT-072 or placebo, QD for 10 days.	Drug: ABT-072; Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.; Drug: Placebo; Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.
Other: 3; Healthy volunteers, receiving 320 mg ABT-072 or placebo, QD for 10 days.	Drug: ABT-072; Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.; Drug: Placebo; Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Analysis of pharmacokinetic results.	Study Days 1-13
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.	Study Days -2 through 39

Secondary Outcome Measures

Outcome Measure	Time Frame
Analysis of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.	Study Day 11-13

Collaborators and Investigators

• Sponsor: Abbott

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: April 27, 2009
• First Submitted That Met QC Criteria: April 28, 2009
• First Posted (Estimate): April 29, 2009

Study Record Updates

• Last Update Posted (Estimate): October 21, 2010
• Last Update Submitted That Met QC Criteria: October 19, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Ketoconazole
• Other Study ID Numbers: M10-705