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

NCT00890318 | Completed Phase 1

• 1 other identifier: M10-705
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

HCV Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Analysis of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.

  Study Day 11-13

Study Arms (3)

1

OTHER

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

Drug: ABT-072; Other: ketoconazole; Drug: Placebo

2

OTHER

Healthy volunteers, receiving 160 mg ABT-072 or placebo, QD for 10 days.

Drug: ABT-072; Drug: Placebo

3

OTHER

Healthy volunteers, receiving 320 mg ABT-072 or placebo, QD for 10 days.

Drug: ABT-072; Drug: Placebo

Interventions

ABT-072 DRUG

Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.

1; 2; 3

ketoconazole OTHER

Tablet, see Arm Description for intervention information.

1

Placebo DRUG

Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.

1; 2; 3

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:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Abbott Clinical Pharmaceutical Research Unit

Waukegan, Illinois, 60085, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

ABT-072; 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 Officials

• Daniel Cohen, MD

  Abbott

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: April 29, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2009
• Last Updated: October 21, 2010

Record last verified: 2010-09

Locations

US (1)