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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Abbott

Criteria

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