HCV Infection
Conditions
Brief summary
The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-072 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-072 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-072
Interventions
DRUGABT-072
Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.
OTHERketoconazole
Tablet, see Arm Description for intervention information.
DRUGPlacebo
Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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
* Use of medications including over the counter and vitamines. * Abuse of alcohol, drugs, or nicotine. * Current diseases or disorders. * History of cardiac disease. * If after consideration by the investigator, for any reason, that you are unsuitable to receive ABT-072.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis of pharmacokinetic results. | Study Days 1-13 |
| 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. | Study Days -2 through 39 |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics. | Study Day 11-13 |
Countries
United States
Outcome results
None listed