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

NCT00752687 | Completed Phase 1

• 1 other identifier: M10-573
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatitis C

Keywords

Phase 1

Outcome Measures

Primary Outcomes (2)

• Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.

  2 weeks

• 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

Study Arms (2)

1

OTHER

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

Drug: ABT-072; Drug: placebo

2

OTHER

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

Drug: ABT-072; Drug: placebo

Interventions

ABT-072 DRUG

Capsule or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.

1; 2

placebo DRUG

Capsule, or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Global Medical Information

Abbott Park, Illinois, 60064, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

ABT-072

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2008
• First Posted: September 15, 2008
• Study Start: September 1, 2008
• Primary Completion: May 1, 2009
• Last Updated: October 21, 2010

Record last verified: 2010-09

Locations

US (1)