Recent Updates
Recently added Catalysts

ABT-072

Phase 2

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

ABT-072 development status

Highest phase Phase 2 run by AbbVie (prior sponsor, Abbott) (NCT00872196)
Phase scored for ABTPhase 1
Registered trials 8 across 2 sponsors since Sep 2008

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials5
Total Enrollment226

FDA Designations

No designations recorded

ABT-072 clinical trials

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
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

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 and HCV Infection. It is intended for use in patients with these conditions, although it is still in clinical development and has not been approved by regulatory authorities.

Who makes ABT-072?

ABT-072 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 Hepatitis C and HCV Infection.

What phase is ABT-072 in?

ABT-072 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety, tolerability, and pharmacokinetic profiles in humans.

What clinical trials is ABT-072 in?

ABT-072 has completed four Phase 1 clinical trials, including NCT00752687, NCT00890318, NCT00982826, and NCT01081483. These trials evaluated the drug in healthy volunteers and patients with Hepatitis C, with a total enrollment of 194 participants across the United States and Japan.

Is ABT-072 the same as any other drug?

ABT-072 is a distinct investigational compound developed by Abbott Laboratories. No alternative names for this drug have been identified in the available information, and it is not known to be the same as any other marketed or investigational medication.