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Lansoprazole and AZD4635 solid formulation

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Jun 28, 2011

Lansoprazole and AZD4635 solid formulation target and mechanism

Molecular targetATP4A, ATP4B
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL480

Also known as lansoprazole

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment149

FDA Designations

No designations recorded

Lansoprazole and AZD4635 solid formulation clinical trials

Lansoprazole and AZD4635 solid formulation · 1 trial · 1 indication

Phase 1 1
NCT01147588Study Evaluating Effect of Esomeprazole, Omeprazole or Lansoprazole on the Pharmacodynamics (PD) and Pharmacokinetics (PK) of ClopidogrelHealthy
COMPLETED149 Analytics
PHASE1COMPLETED
Study Evaluating Effect of Esomeprazole, Omeprazole or Lansoprazole on the Pharmacodynamics (PD) and Pharmacokinetics (PK) of Clopidogrel
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Assess the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the PK profile of clopidogrel active metabolite by assessing the inhibition of platelet aggregation (mIPA).
Baseline

Secondary Endpoints

Assess the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the PK profile of clopidogrel active metabolite by assessing the AUC, AUC 0-t and Cmax after the loading dose of clopidogrel (Day 1) and AUC 0-t, ss and Css, max.
Days 5,14, 29
Evaluate the safety and tolerability of clopidogrel given concomittantly with esomeprazole, omeprazole or lansoprazole by assessment of adverse events and calculation of change from baseline for clinical laboratory tests, vital signs and pECG.
Every in-house day
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTALlansoprazole 60 mg + clopidogrel 300 mg/ 75 mg
2EXPERIMENTALomeprazole 80 mg + clopidogrel 300/75 mg
3EXPERIMENTALesomeprazole 40 mg + clopidogrel 300/75 mg
4EXPERIMENTALclopidogrel 300/75 mg alone

Interventions

NameTypeDescription
lansoprazoleDRUG60 mg (2x30-mg capsule), once daily
omeprazoleDRUG80 mg (2x40-mg capsule), once daily
esomeprazoleDRUG40 mg (1x40-mg capsule), once daily
clopidogrelDRUG300 mg loading dose on Day 1 then 75 mg daily for 28 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males within the age of 18-45 years and females within the age of 18-55 years with suitable veins for cannulation or repeated vein puncture. Females must be of non-childbearing potential. * Weight of 50-95kg, inclusive, and a BMI between 19-30 kg/m2, inclusive. * No cl...

Countries:United States
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Frequently asked questions about Lansoprazole and AZD4635 solid formulation

What is lansoprazole and AZD4635 solid formulation?

Lansoprazole and AZD4635 solid formulation is an investigational small molecule combination developed by AstraZeneca PLC. It pairs lansoprazole, a proton pump inhibitor, with AZD4635 in a single oral solid dose. The combination has been studied in a Phase 1 clinical trial, and the specific indication has not been disclosed.

What does lansoprazole and AZD4635 solid formulation target?

Lansoprazole and AZD4635 solid formulation targets ATP4A and ATP4B, the subunits of the gastric proton pump. It acts as an inhibitor of these targets. This mechanism is associated with suppression of gastric acid secretion, which is the pharmacological basis for including lansoprazole in the combination.

Who makes lansoprazole and AZD4635 solid formulation?

AstraZeneca PLC, which trades under the ticker AZN, is the developer of lansoprazole and AZD4635 solid formulation. The company is responsible for the clinical development of this investigational combination product.

What phase is lansoprazole and AZD4635 solid formulation in?

Lansoprazole and AZD4635 solid formulation is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for this formulation.

What clinical trials is lansoprazole and AZD4635 solid formulation in?

Lansoprazole and AZD4635 solid formulation has been evaluated in one completed Phase 1 trial, NCT01147588. That study enrolled 149 healthy adult volunteers in the United States and examined the effect of esomeprazole, omeprazole, or lansoprazole on the pharmacodynamics and pharmacokinetics of clopidogrel.

Is lansoprazole and AZD4635 solid formulation the same as lansoprazole?

No. Lansoprazole and AZD4635 solid formulation is a combination product that contains lansoprazole plus AZD4635. Lansoprazole alone is a proton pump inhibitor, while the combination is an investigational solid oral formulation developed by AstraZeneca. The two are related but not interchangeable.