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Study of ABT-267 in Both Healthy Volunteers and Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

A Blinded, Randomized, Placebo-Controlled Study in Healthy and HCV Genotype 1-infected Adults, to Evaluate the Safety, Tolerability, Antiviral Activity, Pharmacokinetics (Including the Effect of Food) and Resistance Profile of Single and Multiple Doses of ABT-267

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01181427
Enrollment
137
Registered
2010-08-13
Start date
2010-08-31
Completion date
2012-01-31
Last updated
2012-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCV Infection

Brief summary

Study of ABT-267 in both healthy volunteers and Hepatitis C virus (HCV) genotype 1 infected subjects.

Interventions

DRUGPlacebo

See arms description

PROCEDUREBlood Sample Collection

See arm description

DRUGABT-267

See arm description

DRUGCytochrome P450 inhibitor

See arm description

Sponsors

Abbott
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Main Selection Criteria for Healthy Volunteers: * Subject has provided written consent. * Subject is in general good health. * Females must be post-menopausal for at least 2 years or surgically sterile. * Females must not be pregnant or breast-feeding. If male, subject is surgically sterile or practicing specific forms of birth control. Main Selection Criteria for HCV Genotype 1-infected Volunteers: * Subject has provided written consent. * Subject has chronic HCV genotype 1 infection at screening. * Liver biopsy within 3 years with histology. * Females must be post-menopausal for at least 2 years or surgically sterile. * Females must not be pregnant or breast-feeding. If male, subject is surgically sterile or practicing specific forms of birth control. * Subject is in general good health, as perceived by the investigator, other than HCV infection. Main Selection Criteria for Volunteers in the Resistance Monitoring Portion of the Study: * Subject has provided written consent, has received at least one dose of ABT-267 or placebo in the study, and is considered suitable by the investigator to participate.

Exclusion criteria

Main

Design outcomes

Primary

MeasureTime frame
Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.Up to 15 days or less
Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, vital signs, ECGs, continuous cardiac monitoring, and clinical lab results (including chemistry, hematology and urine).Update to 20 days or less

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026