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

Abbott45 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

Conditions

HCV Infection

Interventions

ABT-333DRUG

Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.

ketoconazoleDRUG

Tablet, see arms for intervention description

placeboDRUG

Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Site Reference ID/Investigator# 12701

Waukegan, Illinois, United States

Outcomes

Primary Outcomes

Analysis of pharmacokinetic results.

Time frame: Approximately 1 week.

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.

Secondary Outcomes

Analysis of single dose administration of ketoconazole on steady state ABT-333 pharmacokinetics.

Time frame: Approximately 1 week.

Data from ClinicalTrials.gov

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