NCT00890318

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• HCV Infection

Interventions

Type	Name	Description
DRUG	ABT-072	Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.
OTHER	ketoconazole	Tablet, see Arm Description for intervention information.
DRUG	Placebo	Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-07-01
• First posted: 2009-04-29
• Last updated: 2010-10-21

Locations

1 site across 1 country: United States