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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00768690

Enrollment

Registered

2008-10-08

Start date

2008-10-31

Completion date

Unknown

Last updated

2010-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCV Infection

Brief summary

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

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

Interventions

DRUGABT-333

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

DRUGketoconazole

Tablet, see arms for intervention description

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Analysis of pharmacokinetic results.	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.	Approximately 1 week.

Secondary

Measure	Time frame
Analysis of single dose administration of ketoconazole on steady state ABT-333 pharmacokinetics.	Approximately 1 week.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026