A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072 Used to Treat Hepatitis C

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Abbott
• Treatments: Ketoconazole

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:

• 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.