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

HCV Infection Clinical Trial

Official title:

A Blinded, Randomized, Placebo-Controlled Study in Healthy and HCV Genotype 1-infected Adults, to Evaluate the Safety, Tolerability, Antiviral Activity, Pharmacokinetics (Including the Effect of Food) and Resistance Profile of Single and Multiple Doses of ABT-267

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181427
• Other study ID #: M12-116
• Status: Completed
• Phase: Phase 1
• First received: August 12, 2010
• Last updated: January 20, 2012
• Start date: August 2010
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: January 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HCV Infection

Intervention

Drug:
• ABT-267
See arm description
• Placebo
See arms description

Procedure:
• Blood Sample Collection
See arm description

Drug:
• Cytochrome P450 inhibitor
See arm description

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 42708	Orlando	Florida
United States	Site Reference ID/Investigator# 42707	San Antonio	Texas
United States	Site Reference ID/Investigator# 43322	Waukegan	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.		Up to 15 days or less	No
Primary	Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, vital signs, ECGs, continuous cardiac monitoring, and clinical lab results (including chemistry, hematology and urine).		Update to 20 days or less	Yes