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

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00768690

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 I

Drug Information available for: Ketoconazole Fungarest

U.S. FDA Resources

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

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. Drug: ketoconazole Tablet, see arms for intervention description Drug: placebo Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.
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. Drug: placebo Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.
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. Drug: placebo Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.
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. Drug: placebo Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.
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. Drug: placebo Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.

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
Global Medical Information
Abbott Park, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

More Information

No publications provided

Responsible Party:	Abbott ( Daniel Cohen, MD/Study Medical Director )
Study ID Numbers:	M10-687
Study First Received:	October 7, 2008
Last Updated:	March 4, 2009
ClinicalTrials.gov Identifier:	NCT00768690 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Clotrimazole
Miconazole
Antifungal Agents

Tioconazole
Healthy
Ketoconazole

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antifungal Agents

Ketoconazole
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009