A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00768690
First received: October 7, 2008
Last updated: October 11, 2010
Last verified: September 2010
  Purpose

The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-333 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-333 pharmacokinetics


Condition Intervention Phase
HCV Infection
Drug: ABT-333
Drug: ketoconazole
Drug: placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Analysis of pharmacokinetic results. [ Time Frame: Approximately 1 week. ] [ 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: Approximately 1 week. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Analysis of single dose administration of ketoconazole on steady state ABT-333 pharmacokinetics. [ Time Frame: Approximately 1 week. ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: October 2008
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Healthy volunteers, receiving daily doses of 200 mg ABT-333 or placebo, BID for 10 days; and on Study Day 11 receiving a single dose of 200 mg ABT-333 or placebo + 400 mg ketoconazole
Drug: ABT-333
Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.
Other Name: ABT-333
Drug: ketoconazole
Tablet, see arms for intervention description
Other Name: ketoconazole
Drug: placebo
Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.
Other Name: placebo
2
Healthy volunteers, receiving 400 mg ABT-333 or placebo, BID
Drug: ABT-333
Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.
Other Name: ABT-333
Drug: placebo
Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.
Other Name: placebo
3
Healthy volunteers, receiving 600mg ABT-333 or placebo, BID
Drug: ABT-333
Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.
Other Name: ABT-333
Drug: placebo
Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.
Other Name: placebo
4
Healthy volunteers, receiving 1000mg ABT-333 or placebo, BID
Drug: ABT-333
Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.
Other Name: ABT-333
Drug: placebo
Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.
Other Name: placebo
5

Healthy volunteers, receiving 1600mg ABT-333 or placebo, BID*

*After review of the data from previous groups, and in accordance with the protocol, this arm was not dosed.

Drug: ABT-333
Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.
Other Name: ABT-333
Drug: placebo
Capsule or powder drug substance from the capsule powder 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-333

  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:

  • See above for main selection criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768690

Locations
United States, Illinois
Site Reference ID/Investigator# 12701
Waukegan, Illinois, United States, 60085
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Daniel Cohen, MD/Study Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00768690     History of Changes
Other Study ID Numbers: M10-687
Study First Received: October 7, 2008
Last Updated: October 11, 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 17, 2014