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Lanthanum carbonate Granule Formulation

Phase 1

End Stage Renal Disease | Small molecule | Nephrology |Takeda Pharmaceutical Company Limited|Last Updated: Jun 11, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

Lanthanum carbonate Granule Formulation · 1 trial · 1 indication

Phase 1 1
NCT00880750Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy AdultsEnd Stage Renal Disease
COMPLETED72 Analytics
PHASE1COMPLETED
Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults
End Stage Renal DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Urinary Phosphate Excretion 3-Day Average
Continuous collection over 3 days

Secondary Endpoints

Urinary Phosphate Excretion on Day 4
Continuous collection on Day 4
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lanthanum Carbonate
3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4
Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate
3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Lanthanum carbonate granulesEXPERIMENTALLanthanum carbonate granulated formulation crossover to chewable tablet formulation
Lanthanum carbonate chewable tablets (Fosrenol)EXPERIMENTALLanthanum carbonate chewable table formulation crossover to granulated formulation

Interventions

NameTypeDescription
Lanthanum carbonate Granule FormulationDRUG3x's per day for 3 days, 1 dose in the am for day 4. (A single dose equals 1000mg of lanthanum carbonate granule formulation. Dose is administered immediately after each meal.)
Lanthanum carbonate Chewable Tablets (Fosrenol)DRUG3x's per day for 3 days, 1 dose on day 4. (A single dose equals a 1000mg tablet of lanthanum carbonate. Dose is administered immediately after each meal.)
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria * Ability to provide informed consent to participate in the study. * Healthy volunteers, age 18-55 inclusive. * Subject must be willing to comply with applicable contraceptive requirements of the protocol * Female subjects must have a negative pregnancy test * Ability to chew and...

Countries:United States
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Frequently asked questions about Lanthanum carbonate Granule Formulation

What is Lanthanum carbonate Granule Formulation used for in End Stage Renal Disease?

Lanthanum carbonate Granule Formulation is an investigational small molecule being studied for use in End Stage Renal Disease. It is a granule formulation of lanthanum carbonate, a phosphate binder. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does Lanthanum carbonate Granule Formulation target?

Lanthanum carbonate Granule Formulation is a phosphate binder. It works by binding to phosphate in the gastrointestinal tract, reducing its absorption. This mechanism is relevant for patients with End Stage Renal Disease who often have elevated phosphate levels. The drug is being developed as a granule formulation for this purpose.

Who makes Lanthanum carbonate Granule Formulation?

Lanthanum carbonate Granule Formulation is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical research on this drug for the treatment of End Stage Renal Disease. The drug is currently in Phase 1 clinical trials.

What phase is Lanthanum carbonate Granule Formulation in?

Lanthanum carbonate Granule Formulation is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for use in End Stage Renal Disease, and its clinical development is at an early stage.

What clinical trials is Lanthanum carbonate Granule Formulation in?

Lanthanum carbonate Granule Formulation has one completed clinical trial, NCT00880750, titled "Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults." This Phase 1 study enrolled 72 participants in the United States and was a controlled, randomized trial. The study involved healthy volunteers aged 18 years and older.

Is Lanthanum carbonate Granule Formulation the same as lanthanum carbonate?

Lanthanum carbonate Granule Formulation is a specific granule formulation of lanthanum carbonate, the active pharmaceutical ingredient. While lanthanum carbonate itself is a known phosphate binder, this granule formulation is being studied as a distinct drug product. It is currently in Phase 1 clinical trials for End Stage Renal Disease.