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ABT-450

Phase 2

HCV Infection | Small molecule | Infectious Disease |Abbott Laboratories|Trials Updated: Oct 13, 2010

ABT-450 development status

Highest phase Phase 2 run by AbbVie (prior sponsor, Abbott) (NCT01221298)
Phase scored for ABTPhase 1
Registered trials 10 across 3 sponsors since Feb 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment46

FDA Designations

No designations recorded

ABT-450 clinical trials

ABT-450 · 2 trials · 1 indication

Phase 1 2
NCT00931281Study in Healthy Adults to Evaluate Pharmacokinetics, Safety and Tolerability of ABT-450 With RitonavirHCV Infection
COMPLETED38 Analytics
NCT00909311Study in Healthy Adults to Evaluate Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With RitonavirHCV Infection
COMPLETED8 Analytics
PHASE1COMPLETED
Study in Healthy Adults to Evaluate Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
HCV InfectionUnlock trial analytics
PHASE1COMPLETED
Study in Healthy Adults to Evaluate Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
HCV InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics (blood draws, pre- and post-dose)
17 days
Safety and Tolerability (ECGs, AEs, vitals, physical exams, routine labs)
30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORABT-450/ritonavir
2PLACEBO_COMPARATORPlacebo for ABT-450/placebo for ritonavir

Interventions

NameTypeDescription
ABT-450DRUGcapsules, QD or BID, 14 days, ascending doses
ritonavirDRUGcapsules, QD or BID, 14 days, ascending doses
Placebo for ABT-450DRUGcapsule, QD or BID, 14 days
Placebo for ritonavirDRUGcapsule, QD or BID, 14 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * overall healthy subjects * non-childbearing potential females included Exclusion Criteria: * history of significant sensitivity to any drug * positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab * history of gastrointestinal issues or procedures * history of seizures...

Countries:United States
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Frequently asked questions about ABT-450

What is ABT-450?

ABT-450 is an investigational small molecule developed by Abbott Laboratories for the treatment of hepatitis C virus (HCV) infection. It was studied in Phase 1 clinical trials, including pharmacokinetic, safety, and tolerability studies in healthy adult volunteers. It is not an approved medicine and remains in early clinical development.

What is ABT-450 used for in HCV infection?

ABT-450 was being developed as a treatment for hepatitis C virus infection. The clinical program evaluated its pharmacokinetics, safety, and tolerability when given with ritonavir in healthy adult volunteers. All reported trials were Phase 1 studies, and no later-stage efficacy trials in patients with HCV infection are listed.

Who makes ABT-450?

ABT-450 was developed by Abbott Laboratories, which trades on the New York Stock Exchange under the ticker ABT. Abbott sponsored the Phase 1 studies of the compound in the United States. The asset is an investigational small molecule for hepatitis C virus infection.

What phase is ABT-450 in?

ABT-450 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with no active trials ongoing. The studies enrolled a combined total of 46 healthy adult volunteers. ABT-450 is investigational and has not been approved for any indication.

What clinical trials is ABT-450 in?

Two completed Phase 1 trials studied ABT-450: NCT00931281, which evaluated pharmacokinetics, safety, and tolerability of ABT-450 with ritonavir in 38 healthy adults, and NCT00909311, which assessed the effect of food on pharmacokinetics, safety, and tolerability in 8 healthy adults. Both were conducted in the United States.

Were the ABT-450 trials randomized and controlled?

Yes. The ABT-450 Phase 1 program was randomized, double-blind, and active-controlled. Both completed trials, NCT00931281 and NCT00909311, enrolled healthy adult volunteers of any sex, aged 18 years and older, in the United States. Combined enrollment across the two studies was 46 participants.