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

Abbott

Status and phase: Completed; Phase 1

Conditions: HCV Infection

Treatments: Drug: Placebo; Procedure: Blood Sample Collection; Drug: Cytochrome P450 inhibitor; Drug: ABT-267

Study type: Interventional

Funder types: Industry

Identifiers

NCT01181427

M12-116

Details and patient eligibility

About

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

Enrollment: 137 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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137 participants in 5 patient groups, including a placebo group

Single Ascending Dose (SAD)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: ABT-267

Multiple Ascending Dose (MAD)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Cytochrome P450 inhibitor

Drug: Placebo

Drug: ABT-267

Food Effect (FE)

Active Comparator group

Description:

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

Treatment:

Drug: ABT-267

Antiviral Activity

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: ABT-267

Resistance Monitoring

No Intervention group

Description:

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

Treatment:

Procedure: Blood Sample Collection