Study of ABT-267 in Both Healthy Volunteers and Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Study of ABT-267 in both healthy volunteers and Hepatitis C virus (HCV) genotype 1 infected subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Abbott
• Treatments: Antiviral Agents; Cytochrome P-450 Enzyme Inhibitors

Criteria

Inclusion Criteria

Main Selection Criteria for Healthy Volunteers:

• Subject has provided written consent.

• Subject is in general good health.

• Females must be post-menopausal for at least 2 years or surgically sterile.

• Females must not be pregnant or breast-feeding. If male, subject is surgically sterile or practicing specific forms of birth control.

Main Selection Criteria for HCV Genotype 1-infected Volunteers:

• Subject has provided written consent.

• Subject has chronic HCV genotype 1 infection at screening.

• Liver biopsy within 3 years with histology.

• Females must be post-menopausal for at least 2 years or surgically sterile.

• Females must not be pregnant or breast-feeding. If male, subject is surgically sterile or practicing specific forms of birth control.

• Subject is in general good health, as perceived by the investigator, other than HCV infection.

Main Selection Criteria for Volunteers in the Resistance Monitoring Portion of the Study:

• Subject has provided written consent, has received at least one dose of ABT-267 or placebo in the study, and is considered suitable by the investigator to participate.

Exclusion Criteria

Main Exclusion Criteria for Healthy Volunteers:

• Positive test for HAV IgM, HBsAg, HCV Ab or HIV Ab.

• Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder.

• Use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration.

• Abnormal screening laboratory results.

• Significant sensitivity to any drug.

• Requirement for any over the counter and/or prescription medication, vitamins and/or herbal supplements on a regular basis.

Main Exclusion Criteria for HCV Genotype 1-infected Volunteers:

• Significant sensitivity to any drug.

• Positive HBsAg, HAV-IgM, and HIV Ab. Use of CYP enzyme inducers or inhibitors within 1 month of dosing.

• Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid disease (except hypothyroidism on stable thyroid replacement therapy), or any uncontrolled medical illness or psychiatric disorder.

• Use of any medications (prescription and over-the counter) within 2 weeks prior to study drug dosing without prior approval by the Abbott Medical Monitor.

• Use of any vitamins or herbal supplements within 2 weeks prior to study drug dosing.

• Prior treatment with any investigational or commercially available anti-HCV agents.

• Abnormal screening laboratory results.