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GLPG3067

Phase 1

Cystic Fibrosis | Small molecule | Respiratory |Lakefront Biotherapeutics|Trials Updated: Jul 17, 2018

GLPG3067 target and mechanism

ModalitySmall molecule

Also known as GLPG3067 single dose

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

GLPG3067 clinical trials

GLPG3067 · 1 trial · 1 indication

Phase 1 1
NCT03589313Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.Cystic Fibrosis
COMPLETED6 Analytics
PHASE1COMPLETED
Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.
Cystic FibrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum observed plasma concentration (cmax) of GLPG3067 single dose.
Between Day 1 pre-dose and Day 4.

To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.

Area under the plasma concentration-time curve from time zero until 24 hours post-dose ( (AUC0-24h) of GLPG3067 single dose.
Between Day 1 pre-dose and Day 4.

To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.

Area under the plasma concentration-time curve from time zero until 72 hours post-dose (AUC0-72h) of GLPG3067 single dose.
Between Day 1 pre-dose and Day 4.

To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.

Secondary Endpoints

The number of subjects with adverse events.
From screening to 19 days after the last dose.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GLPG3067 single dose.EXPERIMENTALSingle Dose of GLPG3067 film coated tablets.

Interventions

NameTypeDescription
GLPG3067 single doseDRUGGLPG3067 film coated tablets provided at Day 1.
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male subject ≥18 years of age on the day of signing the ICF. * A confirmed clinical diagnosis of CF. * Exocrine pancreatic insufficiency (documented in the subject's medical record). * Stable concomitant medication regimen for pulmonary health for at least 2 weeks prior to stu...

Countries:Belgium
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Competitive Landscape -Cystic Fibrosis 20 trials

Frequently asked questions about GLPG3067

What is GLPG3067?

GLPG3067 is an investigational small molecule developed by Lakefront Biotherapeutics (ticker: LKFT) for cystic fibrosis, a respiratory disease. It has been studied in a Phase 1 clinical trial and is not yet approved for any indication.

What is GLPG3067 used for in cystic fibrosis?

GLPG3067 is being developed as a treatment for cystic fibrosis. It is an investigational therapy that has completed a Phase 1 pharmacokinetic study in adult male subjects with the condition, but it has not been approved for clinical use.

Who makes GLPG3067?

GLPG3067 is developed by Lakefront Biotherapeutics, which trades under the ticker symbol LKFT. The company is responsible for the clinical development of this small molecule for cystic fibrosis.

What phase is GLPG3067 in?

GLPG3067 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not received FDA approval.

What clinical trials is GLPG3067 in?

GLPG3067 has been evaluated in a single completed Phase 1 trial, NCT03589313, titled "Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis." The study enrolled 6 male participants in Belgium and was an uncontrolled, non-randomized design.

Is GLPG3067 the same as GLPG3067 single dose?

Yes, GLPG3067 is also referred to as GLPG3067 single dose. This alternative name reflects the single-dose pharmacokinetic study conducted in male subjects with cystic fibrosis.