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

Phase 1

Completed

• Conditions: HCV Infection
• Interventions: Drug: ABT-072; Other: ketoconazole; Drug: Placebo

• Registration Number: NCT00890318
• Lead Sponsor: Abbott

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

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Primary Completion: 2009-07
• Status Verified: 2010-09
• Last Update Submitted: 2010-10-19
• Last Update Posted: 2010-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ABT-072	Healthy volunteers, receiving daily dose of 80 mg ABT-072 or placebo, QD for 10 days; and on Study Day 11 receiving a single dose of 80 mg ABT-072 or placebo + 400 mg ketoconazole
1	ketoconazole	Healthy volunteers, receiving daily dose of 80 mg ABT-072 or placebo, QD for 10 days; and on Study Day 11 receiving a single dose of 80 mg ABT-072 or placebo + 400 mg ketoconazole
1	Placebo	Healthy volunteers, receiving daily dose of 80 mg ABT-072 or placebo, QD for 10 days; and on Study Day 11 receiving a single dose of 80 mg ABT-072 or placebo + 400 mg ketoconazole
2	Placebo	Healthy volunteers, receiving 160 mg ABT-072 or placebo, QD for 10 days.
3	Placebo	Healthy volunteers, receiving 320 mg ABT-072 or placebo, QD for 10 days.
3	ABT-072	Healthy volunteers, receiving 320 mg ABT-072 or placebo, QD for 10 days.
2	ABT-072	Healthy volunteers, receiving 160 mg ABT-072 or placebo, QD for 10 days.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Analysis of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.	Study Day 11-13

Trial Locations

Locations (1)

Abbott Clinical Pharmaceutical Research Unit; 🇺🇸 Waukegan, Illinois, United States