Recent Updates
Recently added Catalysts

GLPG1690

Phase 2

Idiopathic Pulmonary Fibrosis | Small molecule | Respiratory |Lakefront Biotherapeutics|Last Updated: May 4, 2021

Target and mechanism

ModalitySmall molecule

Also known as GLPG1690 single ascending doses, GLPG1690, multiple ascending doses, oral suspension, GLPG1690, multiple ascending doses, GLPG1690 film-coated tablets, GLPG1690 film-coated, [14C]-GLPG1690 solution for infusion, GLPG1690 for infusion, [14C]-GLPG1690 capsules

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

Clinical trial landscape

GLPG1690 · 6 trials · 3 indications

Phase 2 2Phase 1 4
NCT03798366A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Systemic SclerosisSystemic Sclerosis
COMPLETED33 Analytics
NCT02738801Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis
COMPLETED23 Analytics
PHASE2COMPLETED
A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Systemic Sclerosis
Systemic Sclerosis
NCT0379836633
Unlock trial analytics
PHASE2COMPLETED
Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis
NCT0273880123
Unlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in mRSS at Week 4
Baseline, Week 4

The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening.

Change From Baseline in mRSS at Week 8
Baseline, Week 8

The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening.

Change From Baseline in mRSS at Week 16
Baseline, Week 16

The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening.

Change From Baseline in mRSS at Week 24
Baseline, Week 24

The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening.

Number of Patients With Treatment-Emergent Adverse Events (AEs)
From screening up to Day 98
Mean Maximum Observed Plasma Concentration (Cmax; Micrograms Per Milliliter [µg/mL]) of GLPG1690
Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28
Median Time to Occurrence of GLPG1690 Cmax (Tmax; Hours [h])
Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28
Mean Area Under the Plasma Concentration-Time Curve (AUC[t]; µg.h/mL) of GLPG1690
Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28
Mean GLPG1690 Plasma Concentration Observed at Predose (Ctrough; µg/mL)
Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28
Mean Peak Area Ratio of Lysophosphatidic Acid (LPA) C18:2 Species in Blood
Baseline (Day -1), predose and 1.5 and 6 hours postdose on Day 28, predose on Day 84, and Day 98 (or early discontinuation)

LPA species C18:2 concentrations were determined in blood using a validated liquid chromatography tandem mass spectometry (LC/MS-MS) method. The baseline reference timepoint was Day -1 (mean of the pre-dosing duplicates).

Mean Peak Area Ratio of LPA C18:2 Species in Bronchoalveolar Lavage Fluid (BALF)
Baseline (Day -1) and Day 84

LPA species C18:2 concentrations were determined in BALF using a validated LC/MS-MS method. The baseline reference timepoint was Day -1 (mean of the pre-dosing duplicates).

Change of total radioactivity excreted in urine and feces combined (µg) from baseline at Day 10 (Part 2)
From Day 1 pre-dose up to Day 10

To assess the mass balance using \[14C\]-GLPG1690.

Maximum observed plasma concentration (Cmax) of total radioactivity (Part 2).
From Day 1 pre-dose up to Day 10

To assess the pharmacokinetics (PK) of GLPG1690 and its main metabolites in plasma

Maximum observed plasma concentration (Cmax) of GLPG1690 (Part 2).
From Day 1 pre-dose up to Day 10

To assess the pharmacokinetics (PK) of GLPG1690 and its main metabolites in plasma

Area under the plasma concentration-time curve (AUC) of total radioactivity (Part 2).
From Day 1 pre-dose up to Day 10

To assess the PK of GLPG1690 and its main metabolites in plasma

Area under the plasma concentration-time curve (AUC) of GLPG1690 (Part 2).
From Day 1 pre-dose up to Day 10

To assess the PK of GLPG1690 and its main metabolites in plasma

Change in amount of [14C] GLPG1690 excreted in urine and feces combined (µg) from baseline at Day 7 (Part 2).
From Day 1 pre-dose up to Day 7

To better characterize the elimination pathways and metabolite profile of GLPG1690

Maximum observed plasma concentration of GLPG1690 (Cmax).
At various time points between Day 1 pre-dose and Day 5

To investigate the effect of a single oral dose of itraconazole or voriconazole on the single-dose pharmacokinetics of GLPG1690 in healthy male subjects.

Area under the plasma concentration-time curve from time zero to infinity of GLPG1690 (AUC0-∞).
At various time points between Day 1 pre-dose and Day 5

To investigate the effect of a single oral dose of itraconazole or voriconazole on the single-dose pharmacokinetics of GLPG1690 in healthy male subjects.

Apparent terminal half-life of GLPG1690 (t1/2,λz).
At various time points between Day 1 pre-dose and Day 5

To investigate the effect of a single oral dose of itraconazole or voriconazole on the single-dose pharmacokinetics of GLPG1690 in healthy male subjects.

Assessment of the maximum observed plasma concentration of GLPG1690 after single oral doses
predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing

Determine the bioavailability of GLPG1690 by assessing PK parameters

Assessment of the time to reach the maximum observed plasma concentration of GLPG1690 after single oral doses
predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing

Determine the bioavialability of GLPG1690 by assessing PK parameters

Assessment of the time of the last quantifiable plasma concentration of GLPG1690 after single oral doses
predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing

Determine the bioavialability of GLPG1690 by assessing PK parameters

Number of subjects with adverse events
Between screening and 7-10 days after the last dose

To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of adverse events

Number of subjects with abnormal laboratory parameters
Between screening and 7-10 days after the last dose

To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after single and multiple oral dose in healthy subjects in terms of abnormal laboratory parameters

Number of subjects with abnormal vital signs
Between screening and 7-10 days after the last dose

To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal vital signs

Number of subjects with abnormal electrocardiogram
Between screening and 7-10 days after the last dose

To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal electrocardiogram

Number of subjects with abnormal physical examination
Between screening and 7-10 days after the last dose

To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal physical examination

Secondary Endpoints

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Baseline up to end of the study (36 weeks)
Intravenous (IV) maximum observed plasma concentration (Cmax) of [14C]-GLPG1690 microtracer (MT) (Part 1).
From Day 1 pre-dose up to Day 4
Intravenous (IV) maximum observed plasma concentration (Cmax) of total radioactivity (Part 1).
From Day 1 pre-dose up to Day 4
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GLPG1690 600 mgEXPERIMENTALParticipants received GLPG1690 600 milligrams (mg), orally once daily for 24 weeks.
PlaceboPLACEBO_COMPARATORParticipants received GLPG1690 matching placebo, orally once daily for 24 weeks.
GLPG1690 600 mg once daily (QD)EXPERIMENTAL -
Placebo QDPLACEBO_COMPARATOR -
GLPG1690 oral and IVEXPERIMENTALGLPG1690 film-coated tablets followed by \[14C\]-GLPG1690 solution for infusion
[14C]-GLPG1690 capsulesEXPERIMENTAL\[14C\]-GLPG1690 capsules
Treatment AEXPERIMENTALsingle dose GLPG1690.
Treatment BEXPERIMENTALSingle dose itraconazole + single dose GLPG1690.
Treatment CEXPERIMENTALSingle dose voriconazole + single dose GLPG1690.
GLPG1690 single doseEXPERIMENTALSingle oral dose of GLPG1690 suspension or solid formulation - ascending doses
Placebo single dosePLACEBO_COMPARATORSingle oral dose of placebo suspension or solid formulation
GLPG1690 multiple dosesEXPERIMENTALMultiple oral doses of GLPG1690 suspension - ascending doses
Placebo multiple dosesPLACEBO_COMPARATORMultiple oral doses of placebo suspension

Interventions

NameTypeDescription
GLPG1690DRUGFilm-coated tablets of GLPG1690 for oral use.
PlaceboDRUGFilm-coated tablets of GLPG1690 matching placebo for oral use.
GLPG1690 600 mg QDDRUGGLPG1690 capsules, administered at a dose of 600 mg, orally QD
Placebo QDDRUGMatching placebo capsules, administered orally QD
GLPG1690 film-coated tabletsDRUGa single oral dose of GLPG1690
[14C]-GLPG1690 solution for infusionDRUGa 15-minute IV infusion \[14C\]-GLPG1690
[14C]-GLPG1690 capsulesDRUGsingle oral dose of \[14C\]-GLPG1690
ItraconazoleDRUGA single oral dose of itraconazole.
VoriconazoleDRUGA single oral dose of voriconazole.
GLPG1690 single ascending dosesDRUGSingle dose, oral suspension or solid formulation, starting dose of 20mg escalating up to 1500mg
Placebo single ascending dosesDRUGSingle dose, oral suspension or solid formulation matching placebo
GLPG1690, multiple ascending doses, oral suspensionDRUGMultiple doses, daily for 14 days, oral suspension, anticipated doses: 300mg to 1000mg
Placebo, multiple ascending doses, oral suspensionDRUGMultiple doses, daily for 14 days, oral suspension matching placebo
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Able and willing to comply with the protocol requirements and to sign the informed consent form (ICF) as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations. * Male and female participants ≥18 years at the tim...

Countries:United StatesBelgiumGermanyItalySpainUnited KingdomUkraine
Unlock Eligibility Criteria

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
Unlock Competitive Intelligence