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ABT-072

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-BlindCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

ABT-072 · 5 trials · 2 indications

Phase 1 5
NCT01081483A Study of Single Doses of ABT-072 in Japanese Healthy Male AdultsHepatitis C
COMPLETED24 Analytics
NCT00982826Single and Multiple Dose Evaluation of ABT-072 and to Evaluate the Effect of Food on the Pharmacokinetics of ABT-072Hepatitis C
COMPLETED52 Analytics
NCT00947440Evaluation of the Bioavailability of Two ABT-072 Tablet Formulations as Compared to ABT-072 Capsule FormulationHepatitis C
COMPLETED18 Analytics
NCT00890318A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072 Used to Treat Hepatitis CHCV Infection
COMPLETED32 Analytics
NCT00752687A Study of ABT-072 in Healthy and Hepatitis C Virus Genotype 1-Infected AdultsHepatitis C
COMPLETED100 Analytics
PHASE1COMPLETED
A Study of Single Doses of ABT-072 in Japanese Healthy Male Adults
Hepatitis CUnlock trial analytics
PHASE1COMPLETED
Single and Multiple Dose Evaluation of ABT-072 and to Evaluate the Effect of Food on the Pharmacokinetics of ABT-072
Hepatitis CUnlock trial analytics
PHASE1COMPLETED
Evaluation of the Bioavailability of Two ABT-072 Tablet Formulations as Compared to ABT-072 Capsule Formulation
Hepatitis CUnlock trial analytics
PHASE1COMPLETED
A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072 Used to Treat Hepatitis C
HCV InfectionUnlock trial analytics
PHASE1COMPLETED
A Study of ABT-072 in Healthy and Hepatitis C Virus Genotype 1-Infected Adults
Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability assessment
Day 1 to Day 4 and Day 15.

Safety and tolerability assessment by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring.

Pharmacokinetic profile evaluation
Day 1 to Day 4

Single Dose Pharmacokinetic profile evaluation

To determine the single and multiple dose safety and tolerability of the ABT-072 tablet formulation under non-fasting conditions.
Up to 14 days post last dose.
To determine the single and multiple dose safety pharmacokinetics of the ABT-072 tablet formulation under non-fasting conditions.
72 hours post last dose.
To evaluate the relative bioavailability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.
4 days post each dose
Analysis of pharmacokinetic results.
Study Days 1-13
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.
Study Days -2 through 39
Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.
2 weeks

Secondary Endpoints

To assess the effect of food on the pharmacokinetics of the ABT-072 tablet formulation.
72 hours post last dose.
To evaluate safety and tolerability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.
Through 14 days post last dose.
Analysis of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.
Study Day 11-13
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABT-072 TabletACTIVE_COMPARATORABT-072 50 mg Tablet, every day (QD), single ascending doses, groups 1-3
PlaceboPLACEBO_COMPARATORPlacebo Tablet, QD, single doses, groups 1-3
1EXPERIMENTALABT-072 tablet single ascending dose
2EXPERIMENTALPlacebo tablet
3EXPERIMENTALABT-072 tablet administered under non-fasting conditions.
4EXPERIMENTALABT-072 tablet administered under fasting conditions
5EXPERIMENTALABT-072 tablet multiple ascending dose
Tablet 1 vs. CapsuleACTIVE_COMPARATORSingle dose of 2 x 50 mg tablets (Tablet 1) vs. 100 mg ABT-072 (contents of capsules) suspended in liquid.
Tablet 2 vs. CapsuleACTIVE_COMPARATORSingle dose of 2 x 50 mg tablets (Tablet 2) vs. 100 mg ABT-072 (contents from capsules) suspended in liquid.

Interventions

NameTypeDescription
ABT-072DRUGSee arm description for more information
PlaceboDRUGSee arm description for more information
ketoconazoleOTHERTablet, see Arm Description for intervention information.
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Eligibility Criteria

Age Range20 Years to 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overall healthy adult Japanese males Exclusion Criteria: * Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medi...

Countries:JapanUnited States
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Frequently asked questions about ABT-072

What is ABT-072 used for?

ABT-072 is an investigational small molecule being developed for the treatment of Hepatitis C virus (HCV) infection. It was studied in patients with HCV genotype 1 infection, as well as in healthy volunteers, to evaluate its safety, tolerability, and pharmacokinetic profile.

Who makes ABT-072?

ABT-072 is being developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker symbol ABT. The drug has completed Phase 1 clinical trials, but it is not approved and remains in clinical development.

What phase is ABT-072 in?

ABT-072 is in Phase 1 clinical development. All four clinical trials for ABT-072 have been completed, with no active trials currently ongoing. The drug is investigational and has not received FDA approval.

What clinical trials has ABT-072 been in?

ABT-072 has been studied in four completed Phase 1 trials. These include NCT00752687, which enrolled 100 healthy and HCV genotype 1-infected adults in the United States, and NCT00890318, a multiple-dose study in 32 healthy subjects. Other trials are NCT00982826 and NCT01081483.

Is ABT-072 the same as any other drug?

ABT-072 is the primary name used for this investigational compound. No alternative names have been identified for ABT-072 in the available clinical trial data. It is a distinct small molecule being evaluated for the treatment of Hepatitis C.