Expired Study
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Abbott Park, Illinois 60064


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT00752687


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Abbott Park, Illinois 60064
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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