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ABT-450

Phase 1

HCV Infection | Small molecule | Infectious Disease |Abbott Laboratories|Last Updated: Dec 21, 2010

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

Clinical trial landscape

ABT-450 · 3 trials · 2 indications

Phase 1 3
NCT01091649Study in Healthy Adults to Evaluate the Bioavailability of Two Test Tablet Formulations of ABT-450Healthy
COMPLETED40 Analytics
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 the Bioavailability of Two Test Tablet Formulations of ABT-450
HealthyUnlock trial 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

Assessment of Pharmacokinetics of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at low ABT-450/ritonavir
72 hrs post dose
Assessment of Pharmacokinetics of the selected ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at high ABT-450/ritonavir
72 hrs post dose
Pharmacokinetics (blood draws, pre- and post-dose)
17 days
Safety and Tolerability (ECGs, AEs, vitals, physical exams, routine labs)
30 days

Secondary Endpoints

To tabulate treatment emergent adverse events of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir
Through 30 days post last dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
AACTIVE_COMPARATORLow dose ABT-450 capsule and ritonavir capsules (reference).
BACTIVE_COMPARATORLow dose ABT-450 SDD Tablet Form 1 and ritonavir capsules (test 1)
CACTIVE_COMPARATORLow dose ABT-450 SDD Tablet Form 2 and ritonavir capsules (test 2).
DACTIVE_COMPARATORHigh dose ABT-450 capsule and ritonavir capsules (reference).
EACTIVE_COMPARATORHigh dose ABT-450 SDD Tablet Form 1 or 2 and ritonavir capsule (test)
1ACTIVE_COMPARATORABT-450/ritonavir
2PLACEBO_COMPARATORPlacebo for ABT-450/placebo for ritonavir

Interventions

NameTypeDescription
ABT-450DRUGLow dose ABT-450 / ritonavir see Arm Description for more information
ritonavirDRUGritonavir see Arm Description for more information
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 * Positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab * Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic...

Countries:United States
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Frequently asked questions about ABT-450

What is ABT-450 used for?

ABT-450 is an investigational small molecule being studied for the treatment of HCV Infection and for use in Healthy volunteers. It is being developed by Abbott Laboratories (ticker: ABT). The drug is currently in Phase 1 clinical development and is not yet approved.

Who makes ABT-450?

ABT-450 is being developed by Abbott Laboratories, a company traded under the ticker ABT. The drug is an investigational small molecule in Phase 1 clinical trials for HCV Infection and Healthy volunteer studies.

What phase is ABT-450 in?

ABT-450 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for HCV Infection and in Healthy volunteers, with all trials completed.

What clinical trials is ABT-450 in?

ABT-450 has been studied in three completed Phase 1 trials. These include NCT00909311, which evaluated the effect of food on the drug with ritonavir in 8 participants, and NCT00931281, which assessed pharmacokinetics with ritonavir in 38 participants. A third trial, NCT01091649, studied bioavailability of tablet formulations in 40 healthy adults.

Is ABT-450 the same as ABT-450 with ritonavir?

ABT-450 is often studied in combination with ritonavir, a pharmacokinetic enhancer. Clinical trials NCT00909311 and NCT00931281 both evaluated ABT-450 when given with ritonavir. However, ABT-450 itself is the active drug being investigated, and ritonavir is used to boost its levels.