A Study of ABT-072 in Healthy and Hepatitis C Virus Genotype 1-Infected Adults

Abbott

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: placebo; Drug: ABT-072

Study type: Interventional

Funder types: Industry

Identifiers

NCT00752687

M10-573

Details and patient eligibility

About

To evaluate the safety, tolerability and pharmacokinetics of ABT-072 in healthy volunteers and its anti-viral activity in HCV infected subjects.

Full description

A blinded, randomized, placebo-controlled trial to study the safety, tolerability, antiviral activity and pharmacokinetic profiles of ABT-072 in healthy and HCV genotype-1 infected adults.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Criteria for Healthy Adults:

• Informed consent has been obtained
• Subject is in general good health
• If female, then postmenopausal
• If female, then not pregnant
• If male, must be surgically sterile or both he and the partner must use birth control
• Body Mass Index is 18 to 29, inclusive

Criteria for HCV-infected Adults:

• Infected with HCV for at least 6 months as shown by either detectable HCV RNA or reactive antibody, or liver biopsy with pathology indicative of HCV infection, or disclosure of a risk factor
• Subject is infected with HCV genotype 1 with detectable HCV RNA of > 50,000 IU/mL

Exclusion criteria

Criteria for Healthy Adults:

• If female, then pregnant or breast feeding
• Positive HAV-IgM, HBs-Ag, HCV Ab or HIV Ab
• Within 6 months of start of study, drug or alcohol abuse and use of nicotine products
• Alcohol intake within 48 hours prior to study drug administration

Criteria for HCV-infected Adults:

• Need for prescription or over-the-counter medication
• Child Pugh score > 5 or clinical evidence of cirrhosis
• No other cause for liver disease other than HCV infection
• ALT or AST > 4 x ULN
• Creatinine > ULN
• Clinically significant abnormal ECG
• HCV RNA levels above the level of assay quantification
• TSH values outside normal range

Trial design

100 participants in 2 patient groups

1

Other group

Description:

Single dose of ABT-072, dose escalation ranging from 10 mg to 320 mg or placebo in healthy volunteers

Treatment:

Drug: placebo

Drug: ABT-072

2

Other group

Description:

HCV positive subjects administered 160mg ABT-072 or placebo, multi-dose, QD

Treatment:

Drug: placebo

Drug: ABT-072