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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00890318
First received: April 27, 2009
Last updated: October 19, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
HCV Infection
Drug: ABT-072
Other: ketoconazole
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Analysis of pharmacokinetic results. [ Time Frame: Study Days 1-13 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Analysis of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics. [ Time Frame: Study Day 11-13 ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: April 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: ABT-072
Other: ketoconazole
Tablet, see Arm Description for intervention information.
Other Name: ketoconazole
Drug: Placebo
Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.
Other Name: placebo
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.
Other Name: ABT-072
Drug: Placebo
Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.
Other Name: placebo
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.
Other Name: ABT-072
Drug: Placebo
Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.
Other Name: 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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890318

Locations
United States, Illinois
Abbott Clinical Pharmaceutical Research Unit
Waukegan, Illinois, United States, 60085
Sponsors and Collaborators
Abbott
Investigators
Study Director: Daniel Cohen, MD Abbott
  More Information

No publications provided

Responsible Party: Daniel Cohen, MD/Study Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00890318     History of Changes
Other Study ID Numbers: M10-705
Study First Received: April 27, 2009
Last Updated: October 19, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ketoconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014