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GLPG1205

Phase 2

Idiopathic Pulmonary Fibrosis | Small molecule | Respiratory |Lakefront Biotherapeutics|Last Updated: Sep 14, 2021

Target and mechanism

ModalitySmall molecule

Also known as GLPG1205 single ascending doses, oral suspension, GLPG1205 single ascending doses, GLPG1205, multiple ascending doses, oral suspension, GLPG1205, multiple ascending doses, GLPG1205 film-coated tablets, GLPG1205 film-coated, [14C]-GLPG1205 solution for infusion, GLPG1205 for infusion

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment68

FDA Designations

No designations recorded

Clinical trial landscape

GLPG1205 · 8 trials · 4 indications

Phase 2 2Phase 1 6
NCT03725852A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis
COMPLETED68 Analytics
NCT02337608Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative ColitisUlcerative Colitis
COMPLETED64 Analytics
PHASE2COMPLETED
A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis
NCT0372585268
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PHASE2COMPLETED
Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis
Ulcerative Colitis
NCT0233760864
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Study Endpoints

Primary Endpoints

Change From Baseline in Forced Vital Capacity (FVC) at Week 26
Baseline, Week 26

Forced vital capacity (FVC) (in milliliter \[mL\]) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry.

Changes in Mayo score at Week 8
Screening and Week 8

To evaluate the efficacy of GLPG1205 in terms of changes in Mayo score comparing results at Week 8 with baseline between GLPG1205 treated subjects and placebo subjects

Absolute oral bioavailability (F) (%)
Between Day 1 and Day 22

To determine the absolute bioavailability of an oral dose of GLPG1205 relative to an intravenous (i.v.) microtracer dose of \[14C\]-GLPG1205

Recovery of total radioactivity in urine and feces measured as amount of [14C]-GLPG1205 excreted as percentage of the administered dose (Ae%)
Between Day 1 and Day 22

To assess the mass balance recovery after a single oral dose of \[14C\]-GLPG1205

Frequency and severity of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation
From screening through study completion, an average of 3 months

To evaluate the safety and tolerability of single and multiple oral doses of GLPG1205 in healthy male Japanese and Caucasian subjects

Maximum observed plasma concentration (Cmax) of GLPG1205
Between Day 1 pre-dose and Day 18 and at follow-up Day 32

To assess the PK of single and multiple oral doses of GLPG1205 in healthy male Japanese subjects matched with healthy male Caucasian subjects

Area under the plasma concentration-time curve from time zero till 24 hours postdose (AUC 0-24h) of GLPG1205
Between Day 1 pre-dose and Day 18 and at follow-up Day 32

To assess the PK of single oral doses of GLPG1205 in healthy male Japanese subjects matched with healthy male Caucasian subjects

Area under the plasma concentration-time curve over the dosing interval (AUC T) of GLPG1205
Between Day 1 pre-dose and Day 18 and at follow-up Day 32

To assess the PK of multiple oral doses of GLPG1205 in healthy male Japanese subjects matched with healthy male Caucasian subjects

Difference between the number of healthy male subjects from different age groups and placebo subjects with adverse events
From screening until the final follow up visit (day 35)

to assess safety and tolerability in the first placebo controlled part of the study

Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal laboratory evaluations
From screening until the final follow up visit (day 35)

to assess safety and tolerability in the first placebo controlled part of the study

Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal vital signs
From screening until the final follow up visit (day 35)

to assess safety and tolerability in the first placebo controlled part of the study

Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal ECG
From screening until the final follow up visit (day 35)

to assess safety and tolerability in the first placebo controlled part of the study

Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal physical examination
From screening until the final follow up visit (day 35)

to assess safety and tolerability in the first placebo controlled part of the study

Difference between healthy male subjects of different age groups of Cmax of GLPG1205
From day 1 pre-dose until the final follow up visit (day 35)

To assess PK of GLPG1205 in the first part of the study with different age groups

Difference between healthy male subjects of different age groups of tmax of GLPG1205
From day 1 pre-dose until the final follow up visit (day 35)

To assess PK of GLPG1205 in the first part of the study with different age groups

Difference between healthy male subjects of different age groups of AUC0-t of GLPG1205
From day 1 pre-dose until the final follow up visit (day 35)

To assess PK of GLPG1205 in the first part of the study with different age groups

Difference between healthy male subjects of different age groups of apparent terminal half-life (t1/2) of GLPG1205
From day 1 pre-dose until the final follow up visit (day 35)

To assess PK of GLPG1205 in the first part of the study with different age groups

Assessment of Cmax of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
From day 1 pre-dose until the final follow up visit (day 35)

In the open label (part 2) of the study

Assessment of tmax of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
From day 1 pre-dose until the final follow up visit (day 35)

In the open label (part 2) of the study

Assessment of AUC0-t of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
From day 1 pre-dose until the final follow up visit (day 35)

In the open label (part 2) of the study

Assessment of t1/2 of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
From day 1 pre-dose until the final follow up visit (day 35)

In the open label (part 2) of the study

The maximum observed concentration (Cmax) of CYP450 substrates in plasma after multiple oral doses of GLPG1205 or placebo
Between Day 13 and 7 days after the last dose

To characterize the maximum observed concentration (Cmax) of CYP450 substrates in plasma over time after a single dose of a cocktail of CYP450 substrates and multiple doses of GLPG1205 or placebo in healthy male subjects

The time of occurrence of Cmax (tmax) of CYP450 substrates in plasma after multiple oral doses of GLPG1205 or placebo
Between Day 13 and 7 days after the last dose

To characterize the time of occurrence of Cmax (tmax) of CYP450 substrates in plasma after a single dose of a cocktail of CYP450 substrates and multiple doses of GLPG1205 or placebo in healthy male subjects

The area under the plasma concentration versus time curve (AUC) of CYP450 substrates in plasma after multiple oral doses of GLPG1205 or placebo
Between Day 13 and 7 days after the last dose

To characterize the area under the plasma concentration versus time curve (AUC) of CYP450 substrates in plasma after a single dose of a cocktail of CYP450 substrates and multiple doses of GLPG1205 or placebo in healthy male subjects

The apparent terminal half-life (t1/2) of CYP450 substrates in plasma after multiple oral doses of GLPG1205 or placebo
Between Day 13 and 7 days after the last dose

To characterize the apparent terminal half-life (t1/2) of CYP450 substrates in plasma after a single dose of a cocktail of CYP450 substrates and multiple doses of GLPG1205 or placebo in healthy male subjects

The metabolite over parent AUC ratio (R) of CYP450 substrates in plasma after multiple oral doses of GLPG1205 or placebo
Between Day 13 and 7 days after the last dose

To characterize the metabolite over parent AUC ratio (R) of CYP450 substrates in plasma after a single dose of a cocktail of CYP450 substrates and multiple doses of GLPG1205 or placebo in healthy male subjects

The amount of GLPG1205 in plasma
From predose up to 504 hours (Day 22) after study drug administration

To characterize and compare the amount of GLPG1205 in plasma ( relative bioavailability) in male healthy subjects after a single administration of a capsule formulation in a fasted versus fed condition.

Safety and tolerability after single dose
Between screening and 7-10 days after the last dose

To evaluate the safety and tolerability of GLPG1205 in comparison with placebo after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments

Safety and tolerability after multiple doses
Between screening and 7-10 days after the last dose

To evaluate the safety and tolerability of GLPG1205 in comparison with placebo after multiple oral doses daily for 14 days in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments

Secondary Endpoints

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Related to Study Drug, and TEAEs Leading to Study Drug Discontinuation
First dose date up to 30 days after the last dose of study drug (maximum up to 263 days)
Time to Any Major Events Depicted by Cumulative Percentage of Participants With All-cause Deaths, Respiratory-related Deaths, All-cause Hospitalizations, and Respiratory-related Hospitalizations
Day 1 up to Week 30
Change From Baseline in Total Distance Walked in Six-minute Walk Test (6MWT) at Week 26
Baseline, Week 26
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GLPG1205 100 mgEXPERIMENTALParticipants will receive GLPG1205 100 milligrams (mg) (2 capsules x 50 mg), orally once daily for 26 weeks in addition to the local standard of care. Standard of care includes nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
PlaceboPLACEBO_COMPARATORParticipants will receive GLPG1205 matching placebo, orally once daily (as 2 capsules) for 26 weeks in addition to the local standard of care. Standard of care includes nintedanib, pirfenidone, or neither nintedanib nor pirfenidone.
GLPG1205 100mg QDEXPERIMENTALGLPG1205 100mg daily dosing in the morning
GLPG1205 oral and [14C]-GLPG1205 IVEXPERIMENTALSingle oral dose of GLPG1205 followed by \[14C\]-GLPG1205 solution for infusion
[14C]-GLPG1205 capsuleEXPERIMENTALSingle oral dose of GLPG1205 as solid formulation
GLPG1205 dose AEXPERIMENTALParticipants will receive a single dose with dose A of GLPG1205 on Day 1 in Period 1, and 14 days q.d. dosing on Days 1 to 14 in Period 2.
Placebo dose APLACEBO_COMPARATORParticipants will receive a single dose placebo on Day 1 in Period 1, and 14 days q.d. dosing on Days 1 to 14 in Period 2.
GLPG1205 dose BEXPERIMENTALParticipants will receive 14 days q.d. dosing with dose B of GLPG1205 on Days 1 to 14.
Placebo dose BPLACEBO_COMPARATORParticipants will receive 14 days q.d. dosing placebo on Days 1 to 14.
GLPG1205 50mg q.d.EXPERIMENTALoral hard gelatin capsules with 50 mg GLPG1205 for q.d. administration - compared to placebo
GLPG1205 250 mg loading and 50mg q.d. maintenanceEXPERIMENTALopen label - oral hard gelatin capsules with 50 mg GLPG1205 for one time 250 mg loading dose and subsequent 50mg q.d. administration
GLPG1205 and single CYP450 substrate cocktail doseEXPERIMENTALDaily GLPG1205 administration from Day 1 to Day 12 Single GLPG1205 co-administration on Day 13 with CYP450 substrate cocktail
Placebo and single CYP450 substrate cocktail dosePLACEBO_COMPARATORDaily Placebo administration from Day 1 to Day 12 Single Placebo co-administration on Day 13 with CYP450 substrate cocktail
100 mg GLPG1205 fastedEXPERIMENTALSingle dose of 100 mg GLPG1205 as two capsules of 50 mg after an overnight fast
100 mg GLPG1205 fedEXPERIMENTALSingle dose of 100 mg GLPG1205 as two capsules of 50 mg exactly 30 minutes after the start of a high-fat, high-calorie breakfast
GLPG1205 single doseEXPERIMENTALSingle oral dose of GLPG1205 suspension - ascending doses
Placebo single dosePLACEBO_COMPARATORSingle oral dose of placebo suspension
GLPG1205 multiple dosesEXPERIMENTALMultiple oral doses of GLPG1205 suspension - ascending doses
Placebo multiple dosesPLACEBO_COMPARATORMultiple oral doses of placebo suspension

Interventions

NameTypeDescription
GLPG1205DRUGGLPG1205 will be provided as an oral hard gelatin capsule.
PlaceboDRUGGLPG1205 matching placebo will be provided as an oral hard gelatin capsule.
GLPG1205 film-coated tabletsDRUGSingle oral dose of GLPG1205
[14C]-GLPG1205 solution for infusionDRUGA 15-minute IV infusion of \[14C\]-GLPG1205
GLPG1205 capsulesDRUGSingle oral dose of GLPG1205 as solid formulation
GLPG1205 50mg q.d.DRUGoral gelatin capsule containing 50mg GLPG1205 for q.d. administration - compared to placebo
Placebo oral capsuleDRUGoral gelatin capsule containing placebo to match study arm 1 - q.d. administration
GLPG1205 250 loading dose and 50mg q.d. maintenance doseDRUGOpen label - oral gelatin capsule containing 50mg GLPG1205 for one time 250mg loading dose and subsequent q.d. administration
Cocktail of CYP450 substratesDRUGSingle administration on Day 13 of cocktail of CYP450 substrates: warfarin tablet, omeprazole capsule and caffeine oral solution
100 mg GLPG1205DRUGA single dose of 100 mg GLPG1205 administered as two capsules of 50 mg
GLPG1205 single ascending doses, oral suspensionDRUGSingle dose, oral suspension at 10 mg/mL or 50 mg/mL, starting dose of 10mg escalating up to 800mg
Placebo single ascending doses, oral suspensionDRUGSingle dose, oral suspension matching placebo
GLPG1205, multiple ascending doses, oral suspensionDRUGMultiple doses, daily for 14 days, oral suspension at 10 mg/mL or 50 mg/mL, anticipated doses: 100mg to 400mg
Placebo, multiple ascending doses, oral suspensionDRUGMultiple doses, daily for 14 days, oral suspension matching placebo
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion criteria: Participants who meet all of the following criteria are eligible for the study: * A diagnosis of IPF within 5 years prior to the screening visit as per applicable American Thoracic Society (ATS)/European Respiratory Society(ERS)/Japanese Respiratory Society (JRS)/Latin American...

Countries:BulgariaCroatiaFinlandFranceOmanRomaniaSlovakiaSwedenUkraineBelgiumCzechiaGermanyHungaryPolandRussiaUnited KingdomUnited States
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Competitive Landscape -Idiopathic Pulmonary Fibrosis 19 trials

Top 9 of 10 competitors

CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY2PHASE3BMS-986278
United Therapeutics CorporationUTHR2PHASE3Tyvaso (treprostinil)
AbbVie, Inc.ABBV2PHASE2ABBV-142
PureTech Health PLC Sponsored ADRPRTC2PHASE3Deupirfenidone
Syndax Pharmaceuticals IncSNDX1PHASE2Axatilimab
Contineum Therapeutics, Inc. Class ACTNM1PHASE2PIPE-791
Rein Therapeutics, IncRNTX1PHASE2LTI-03
Cumberland Pharmaceuticals Inc.CPIX1PHASE2Ifetroban
Avalyn Pharma IncAVLN3PHASE2AP01, AP02
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