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

NCT ID: NCT01181427

Last Updated: 2012-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-01-31

Brief Summary

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

Conditions

HCV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Single Ascending Dose (SAD)

Healthy volunteers, receiving single ascending doses of ABT-267 or placebo.

Group Type: PLACEBO_COMPARATOR

ABT-267

Intervention Type: DRUG

See arm description

Placebo

Intervention Type: DRUG

See arms description

Multiple Ascending Dose (MAD)

Healthy volunteers, receiving multiple ascending doses of ABT-267 or placebo, OR, multiple doses of ABT-267 + single dose of a Cytochrome P450 inhibitor or placebo + single dose of a Cytochrome P450 inhibitor.

Group Type: PLACEBO_COMPARATOR

ABT-267

Intervention Type: DRUG

See arm description

Placebo

Intervention Type: DRUG

See arms description

Cytochrome P450 inhibitor

Intervention Type: DRUG

See arm description

Food Effect (FE)

Healthy volunteers, receiving ABT-267, multi-dose, food effect.

Group Type: ACTIVE_COMPARATOR

ABT-267

Intervention Type: DRUG

See arm description

Antiviral Activity

HCV genotype 1-infected treatment naïve subjects receiving multiple ascending doses of ABT-267 or placebo monotherapy for 3 days.

Group Type: PLACEBO_COMPARATOR

ABT-267

Intervention Type: DRUG

See arm description

Placebo

Intervention Type: DRUG

See arms description

Resistance Monitoring

HCV genotype 1-infected treatment naïve subjects, receiving at least one dose of ABT-267 or placebo in the "Antiviral Activity" arm, follow-up to monitor resistance developed to ABT-267, no treatment and only blood samples will be collected

Group Type: NO_INTERVENTION

Blood Sample Collection

Intervention Type: PROCEDURE

See arm description

Interventions

ABT-267

See arm description

Intervention Type: DRUG

Placebo

See arms description

Intervention Type: DRUG

Blood Sample Collection

See arm description

Intervention Type: PROCEDURE

Cytochrome P450 inhibitor

See arm description

Intervention Type: DRUG

Eligibility 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

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Campbell, MD

Role: STUDY_DIRECTOR

Abbott

Locations

Site Reference ID/Investigator# 42708

Orlando, Florida, United States

Site Reference ID/Investigator# 43322

Waukegan, Illinois, United States

Site Reference ID/Investigator# 42707

San Antonio, Texas, United States

Countries

United States

References

Krishnan P, Beyer J, Mistry N, Koev G, Reisch T, DeGoey D, Kati W, Campbell A, Williams L, Xie W, Setze C, Molla A, Collins C, Pilot-Matias T. In vitro and in vivo antiviral activity and resistance profile of ombitasvir, an inhibitor of hepatitis C virus NS5A. Antimicrob Agents Chemother. 2015 Feb;59(2):979-87. doi: 10.1128/AAC.04226-14. Epub 2014 Dec 1.

Reference Type: DERIVED

PMID: 25451055 (View on PubMed)

Other Identifiers

M12-116

Identifier Type: -

Identifier Source: org_study_id