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GLPG0187 prodrug

Phase 1

Undisclosed | Small molecule | Other |Lakefront Biotherapeutics|Trials Updated: Apr 20, 2012

GLPG0187 prodrug development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2012

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

GLPG0187 prodrug clinical trials

GLPG0187 prodrug · 1 trial · 1 indication

Phase 1 1
NCT01580644Bioavailability Study of Prodrug of GLPG0187 in Healthy VolunteersHealthy
COMPLETED12 Analytics
PHASE1COMPLETED
Bioavailability Study of Prodrug of GLPG0187 in Healthy Volunteers
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Study Endpoints

Primary Endpoints

The amount of GLPG0187 in plasma over time after a single oral dose of either of 2 formulations of GLPG0187 prodrug

To characterize the amount of GLPG0187 in plasma over time - pharmacokinetics (PK) - after a single oral dose of either of 2 formulations of GLPG0187 prodrug in healthy subjects

Secondary Endpoints

The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug with food
The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug at a higher dose (with or without food)
Number of adverse events
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Period 1: formulation 1 oral solutionEXPERIMENTAL -
Period 2: formulation 2 capsuleEXPERIMENTAL -
Period 3: Selected formulation + foodEXPERIMENTAL -
Period 4: Selected formulation at higher doseEXPERIMENTAL -

Interventions

NameTypeDescription
GLPG0187 prodrugDRUG -
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Eligibility Criteria

Age Range18 Years to 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male, age 18-50 years * BMI between 18-30 kg/m2 Exclusion Criteria: * Any condition that might interfere with the procedures or tests in this study * Drug or alcohol abuse * Smoking

Countries:Belgium
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Frequently asked questions about GLPG0187 prodrug

What is GLPG0187 prodrug?

GLPG0187 prodrug is an investigational small molecule developed by Lakefront Biotherapeutics. It was studied in a Phase 1 bioavailability trial in healthy volunteers. The compound is a prodrug form of GLPG0187, meaning it is designed to be converted in the body after administration. Its clinical development remains at the early Phase 1 stage.

Who makes GLPG0187 prodrug?

GLPG0187 prodrug is being developed by Lakefront Biotherapeutics, which trades under the ticker LKFT. The company sponsored the Phase 1 bioavailability study of the compound. Lakefront Biotherapeutics is the developer associated with this asset.

What phase is GLPG0187 prodrug in?

GLPG0187 prodrug is in Phase 1 clinical development. It has completed one Phase 1 trial, a bioavailability study conducted in healthy volunteers in Belgium. No later-stage trials have been recorded, and the drug is not approved for any indication. It remains an investigational agent.

What clinical trials is GLPG0187 prodrug in?

GLPG0187 prodrug has been studied in one completed Phase 1 trial, NCT01580644, titled Bioavailability Study of Prodrug of GLPG0187 in Healthy Volunteers. The trial enrolled 12 male participants aged 18 years and older in Belgium. It was a controlled study with no randomization or blinding and has completed.

What was the design of the GLPG0187 prodrug bioavailability trial?

The Phase 1 trial NCT01580644 evaluated the bioavailability of GLPG0187 prodrug in healthy volunteers. It enrolled 12 male participants aged 18 years and older in Belgium. The study was controlled but not randomized and not double-blind. It has completed, and no active trials of GLPG0187 prodrug are ongoing.