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
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: 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 July 24, 2014