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APL180

Phase 1

Coronary Heart Disease | Small molecule | Cardiovascular |Novartis AG|Last Updated: Dec 24, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment280

FDA Designations

No designations recorded

Clinical trial landscape

APL180 · 2 trials · 1 indication

Phase 1 2
NCT00907998Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180Coronary Heart Disease
COMPLETED104 Analytics
NCT00568594Safety and Efficacy of APL180 in Healthy Volunteers and Patients With Coronary Heart Disease (CHD)Coronary Heart Disease
COMPLETED176 Analytics
PHASE1COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180
Coronary Heart DiseaseUnlock trial analytics
PHASE1COMPLETED
Safety and Efficacy of APL180 in Healthy Volunteers and Patients With Coronary Heart Disease (CHD)
Coronary Heart DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of APL180
Throughout the study
Safety and tolerability, pharmacokinetics and effects on biomarkers of HDL function of APL180 after a single and 7-daily infusions in healthy volunteers (HV) and in patients with coronary heart disease (CHD)
throughout the study

Secondary Endpoints

Pharmacokinetics of APL180
Throughout the study
Evaluate effects of APL180 biomarkers
Throughout the study
Pharmacokinetic-pharmacodynamic relationship of APL180
Throughout the study
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
APL180 (first dose level)EXPERIMENTAL -
APL180 (second dose level)EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
APL180DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Male and female CHD or CHD equivalent patients * Body mass index (BMI) must be within the range of 20 to 35 kg/m2, * Patient must have been on a stable statin therapy for \>8 weeks prior to first dose except for the statin intolerant patients. Exclusion criteria: * Pregnancy...

Countries:United StatesDenmarkGermanyIsraelNetherlandsBelgiumSouth AfricaUnited Kingdom
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Frequently asked questions about APL180

What is APL180 used for in Coronary Heart Disease?

APL180 is an investigational small molecule being developed for Coronary Heart Disease. It is a Phase 1 drug candidate that has been studied in clinical trials for this condition. The drug is not approved and remains in clinical development.

Who makes APL180?

APL180 is being developed by Novartis AG, a global pharmaceutical company listed on the stock exchange under the ticker NVS. The drug is currently in Phase 1 clinical development for Coronary Heart Disease.

What phase is APL180 in?

APL180 is in Phase 1 clinical development. It has completed two Phase 1 trials, with a total of 280 participants enrolled. The drug is investigational and has not been approved for any use.

What clinical trials is APL180 in?

APL180 has completed two Phase 1 trials: NCT00568594, which enrolled 176 participants including healthy volunteers and patients with Coronary Heart Disease, and NCT00907998, which enrolled 104 participants. Both trials were completed and evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics.

Is APL180 the same as any other drug?

APL180 is the primary name for this investigational drug candidate. No alternative names have been reported for this compound in the available clinical trial information.