Status:
COMPLETED
Study of ABT-267 in Both Healthy Volunteers and Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
Lead Sponsor:
Abbott
Conditions:
HCV Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Study of ABT-267 in both healthy volunteers and Hepatitis C virus (HCV) genotype 1 infected subjects.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT01181427
Start Date
August 1 2010
End Date
January 1 2012
Last Update
January 24 2012
Active Locations (3)
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1
Site Reference ID/Investigator# 42708
Orlando, Florida, United States, 32809
2
Site Reference ID/Investigator# 43322
Waukegan, Illinois, United States, 60085
3
Site Reference ID/Investigator# 42707
San Antonio, Texas, United States, 78215