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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
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: 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
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014