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

Hepatitis C Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00752687
• Other study ID #: M10-573
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2008
• Last updated: October 19, 2010
• Start date: September 2008

Study information

• Verified date: September 2010
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Drug:
• ABT-072
Capsule or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.
• placebo
Capsule, or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.

Locations

Country	Name	City	State
United States	Global Medical Information	Abbott Park	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.		2 weeks	No
Primary	Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.		2 weeks	Yes