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ABT-267

Phase 1

HCV Infection | Small molecule | Infectious Disease |Abbott Laboratories|Last Updated: Jan 24, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment137

FDA Designations

No designations recorded

Clinical trial landscape

ABT-267 · 1 trial · 1 indication

Phase 1 1
NCT01181427Study of ABT-267 in Both Healthy Volunteers and Hepatitis C Virus (HCV) Genotype 1 Infected SubjectsHCV Infection
COMPLETED137 Analytics
PHASE1COMPLETED
Study of ABT-267 in Both Healthy Volunteers and Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
HCV InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single Ascending Dose (SAD)PLACEBO_COMPARATORHealthy volunteers, receiving single ascending doses of ABT-267 or placebo.
Multiple Ascending Dose (MAD)PLACEBO_COMPARATORHealthy volunteers, receiving multiple ascending doses of ABT-267 or placebo, OR, multiple doses of ABT-267 + single dose of a Cytochrome P450 inhibitor or placebo + single dose of a Cytochrome P450 inhibitor.
Food Effect (FE)ACTIVE_COMPARATORHealthy volunteers, receiving ABT-267, multi-dose, food effect.
Antiviral ActivityPLACEBO_COMPARATORHCV genotype 1-infected treatment naïve subjects receiving multiple ascending doses of ABT-267 or placebo monotherapy for 3 days.
Resistance MonitoringNO_INTERVENTIONHCV genotype 1-infected treatment naïve subjects, receiving at least one dose of ABT-267 or placebo in the "Antiviral Activity" arm, follow-up to monitor resistance developed to ABT-267, no treatment and only blood samples will be collected

Interventions

NameTypeDescription
ABT-267DRUGSee arm description
PlaceboDRUGSee arms description
Blood Sample CollectionPROCEDURESee arm description
Cytochrome P450 inhibitorDRUGSee arm description
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

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 surgic...

Countries:United States
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Frequently asked questions about ABT-267

What is ABT-267 used for?

ABT-267 is an investigational small molecule being developed for the treatment of HCV Infection, specifically hepatitis C virus genotype 1 infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes ABT-267?

ABT-267 is being developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker symbol ABT. The drug is in Phase 1 clinical development for the treatment of HCV Infection.

What phase is ABT-267 in?

ABT-267 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of HCV Infection.

What clinical trials is ABT-267 in?

ABT-267 has been studied in one completed Phase 1 clinical trial, NCT01181427, which enrolled 137 participants. The trial was a randomized, double-blind, placebo-controlled study conducted in the United States, evaluating the drug in healthy volunteers and subjects with hepatitis C virus genotype 1 infection.

Is ABT-267 FDA approved?

ABT-267 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of HCV Infection. The drug has completed one Phase 1 trial, but it remains under clinical investigation and has not received marketing approval.

How does ABT-267 work?

ABT-267 is a small molecule being developed for the treatment of HCV Infection. The specific molecular target of ABT-267 has not been disclosed in available information, so its exact mechanism of action is not publicly detailed.