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ABT-333

Phase 1

HCV Infection | Small molecule | Infectious Disease |Abbott Laboratories|Last Updated: Oct 25, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment103

FDA Designations

No designations recorded

Clinical trial landscape

ABT-333 · 4 trials · 2 indications

Phase 1 4
NCT00919490A Study of Single Dose of ABT-333 in Healthy Male AdultsHCV Infections
COMPLETED39 Analytics
NCT00909636A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of the ABT-333 TabletHCV Infection
COMPLETED24 Analytics
NCT00895102Bioavailability of ABT-333 Tablet Versus First in Human (FIH) Capsule Formulation and Safety, Tolerability and PK Study of Single Doses of ABT-333 in Healthy VolunteersHCV Infection
COMPLETED34 Analytics
NCT00768690A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333HCV Infection
COMPLETED45 Analytics
PHASE1COMPLETED
A Study of Single Dose of ABT-333 in Healthy Male Adults
HCV InfectionsUnlock trial analytics
PHASE1COMPLETED
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of the ABT-333 Tablet
HCV InfectionUnlock trial analytics
PHASE1COMPLETED
Bioavailability of ABT-333 Tablet Versus First in Human (FIH) Capsule Formulation and Safety, Tolerability and PK Study of Single Doses of ABT-333 in Healthy Volunteers
HCV InfectionUnlock trial analytics
PHASE1COMPLETED
A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333
HCV InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess single dose safety and tolerability of an ABT-333 tablet formulation relative to placebo by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring
Daily assessment for 5 days then day 30 or more frequently as needed
To evaluate single dose pharmacokinetics of an ABT-333 tablet formulation
Day 1-3
To assess multiple dose safety and tolerability of an ABT-333 tablet formulation relative to placebo by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring.
10 days
Values for the pharmacokinetic parameters of ABT-333 will be evaluated after pre- and post-dose blood draws.
10 days
To determine relative bioavailability of the ABT-333 tablet formulation compared to the FIH capsule formulation
2 days post dosing
To evaluate single dose safety and tolerability of a ABT-333 tablet formulation relative to placebo
2 days post dosing
To evaluate single dose pharmacokinetics of a ABT-333 tablet formulation
2 days post dosing
Pharmacokinetics
5 days
Analysis of pharmacokinetic results.
Approximately 1 week.
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.
Approximately 1 week.

Secondary Endpoints

Analysis of single dose administration of ketoconazole on steady state ABT-333 pharmacokinetics.
Approximately 1 week.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALSingle dose of 400 mg
Group 2EXPERIMENTALSingle dose of 800 mg after safety evolution of Group I
Group 3EXPERIMENTALSingle dose of 1200 mg after safety evolution of Group 2
Group 4EXPERIMENTALSingle dose of 1600 mg after safety evolution of Group 3
Group 5PLACEBO_COMPARATORSingle dose of placebo
1. ABT-333 TabletACTIVE_COMPARATORThree 400mg ABT-333 Tablets, BID
2. ABT-333 TabletACTIVE_COMPARATORFour 400mg ABT-333 Tablets, BID
3. PlaceboPLACEBO_COMPARATORThree or four placebo tablets, BID
1. ABT-333 Capsule vs ABT-333 TabletACTIVE_COMPARATOR400mg ABT-333 Tablet, QD, single dose vs eight 50mg ABT-333 Capsules, QD, single dose
1OTHERHealthy volunteers, receiving daily doses of 200 mg ABT-333 or placebo, BID for 10 days; and on Study Day 11 receiving a single dose of 200 mg ABT-333 or placebo + 400 mg ketoconazole
2OTHERHealthy volunteers, receiving 400 mg ABT-333 or placebo, BID
3OTHERHealthy volunteers, receiving 600mg ABT-333 or placebo, BID
4OTHERHealthy volunteers, receiving 1000mg ABT-333 or placebo, BID
5OTHERHealthy volunteers, receiving 1600mg ABT-333 or placebo, BID\* \*After review of the data from previous groups, and in accordance with the protocol, this arm was not dosed.

Interventions

NameTypeDescription
ABT-333DRUGTablet, see arms for interventional description
PlaceboDRUGTablet, see arms for interventional description.
ABT-333 TabletDRUGSee Arm Description for more information.
ABT-333 CapsuleDRUGSee arm description for more information
ketoconazoleDRUGTablet, see arms for intervention description
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Eligibility Criteria

Age Range20 Years to 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subject has provided written consent. * Subject is in general good health. Exclusion Criteria: * See above for main selection criteria.

Countries:JapanUnited States
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Frequently asked questions about ABT-333

What is ABT-333 used for?

ABT-333 is an investigational small molecule being developed for the treatment of HCV infection, also referred to as HCV infections. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes ABT-333?

ABT-333 is being developed by Abbott Laboratories, a company traded on the 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-333 in?

ABT-333 is in Phase 1 clinical development. It is an investigational drug for the treatment of HCV infection and has not yet been approved by regulatory authorities. All completed trials for ABT-333 are Phase 1 studies.

What clinical trials is ABT-333 in?

ABT-333 has been studied in four completed Phase 1 clinical trials, including NCT00768690, NCT00895102, NCT00909636, and NCT00919490. These trials evaluated the safety, tolerability, and pharmacokinetics of the drug in healthy volunteers with HCV infection.

Is ABT-333 the same as any other drug?

ABT-333 is not known to have any alternative names. It is an investigational small molecule being developed by Abbott Laboratories for the treatment of HCV infection, and it is currently in Phase 1 clinical development.