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

NCT00768690 | Completed Phase 1

• 1 other identifier: M10-687
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

HCV Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Analysis of single dose administration of ketoconazole on steady state ABT-333 pharmacokinetics.

  Approximately 1 week.

Study Arms (5)

1

OTHER

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

Drug: ABT-333; Drug: ketoconazole; Drug: placebo

2

OTHER

Healthy volunteers, receiving 400 mg ABT-333 or placebo, BID

Drug: ABT-333; Drug: placebo

3

OTHER

Healthy volunteers, receiving 600mg ABT-333 or placebo, BID

Drug: ABT-333; Drug: placebo

4

OTHER

Healthy volunteers, receiving 1000mg ABT-333 or placebo, BID

Drug: ABT-333; Drug: placebo

5

OTHER

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.

Drug: ABT-333; Drug: placebo

Interventions

ABT-333 DRUG

Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.

1; 2; 3; 4; 5

ketoconazole DRUG

Tablet, see arms for intervention description

1

placebo DRUG

Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.

1; 2; 3; 4; 5

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• See above for main selection criteria

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Site Reference ID/Investigator# 12701

Waukegan, Illinois, 60085, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

dasabuvir; Ketoconazole

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: October 1, 2008
• Primary Completion: February 1, 2009
• Last Updated: October 13, 2010

Record last verified: 2010-09

Locations

US (1)