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

Phase 1

Completed

• Conditions: HCV Infection
• Interventions: Drug: ABT-333; Drug: ketoconazole; Drug: placebo

• Registration Number: NCT00768690
• Lead Sponsor: Abbott

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

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-07
• Study First Submitted QC: 2008-10-07
• Study First Posted: 2008-10-08
• Primary Completion: 2009-02
• Status Verified: 2010-09
• Last Update Submitted: 2010-10-11
• Last Update Posted: 2010-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	placebo	Healthy volunteers, receiving daily doses of 200 mg ABT-333 or placebo, BID for 10 days; and on Study Day 11 receiving a single dose of 200 mg ABT-333 or placebo + 400 mg ketoconazole
2	ABT-333	Healthy volunteers, receiving 400 mg ABT-333 or placebo, BID
5	placebo	Healthy volunteers, receiving 1600mg ABT-333 or placebo, BID\* \*After review of the data from previous groups, and in accordance with the protocol, this arm was not dosed.
2	placebo	Healthy volunteers, receiving 400 mg ABT-333 or placebo, BID
4	ABT-333	Healthy volunteers, receiving 1000mg ABT-333 or placebo, BID
3	placebo	Healthy volunteers, receiving 600mg ABT-333 or placebo, BID
4	placebo	Healthy volunteers, receiving 1000mg ABT-333 or placebo, BID
3	ABT-333	Healthy volunteers, receiving 600mg ABT-333 or placebo, BID
5	ABT-333	Healthy volunteers, receiving 1600mg ABT-333 or placebo, BID\* \*After review of the data from previous groups, and in accordance with the protocol, this arm was not dosed.
1	ABT-333	Healthy volunteers, receiving daily doses of 200 mg ABT-333 or placebo, BID for 10 days; and on Study Day 11 receiving a single dose of 200 mg ABT-333 or placebo + 400 mg ketoconazole
1	ketoconazole	Healthy volunteers, receiving daily doses of 200 mg ABT-333 or placebo, BID for 10 days; and on Study Day 11 receiving a single dose of 200 mg ABT-333 or placebo + 400 mg ketoconazole

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Site Reference ID/Investigator# 12701; 🇺🇸 Waukegan, Illinois, United States