Trial · NCT02738801

Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

NCT02738801, Phase 2, Completed, Lakefront Biotherapeutics NV; results first posted 2020-11-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF). Trials, record NCT02738801. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02738801

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
NCT number: NCT02738801
Status: Completed
Phases: Phase 2
Enrollment: 23 participants, actual
Lead sponsor: Lakefront Biotherapeutics NV
Conditions: Idiopathic Pulmonary Fibrosis
Interventions: GLPG1690 600 mg QD, Placebo QD
First posted: 2016-04-14
Last updated: 2020-11-06
Other registries' IDs: eudract:2015-004157-41
Results first posted: 2020-11-06
Limitations and caveats: None reported.

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Patients With Treatment-Emergent Adverse Events (AEs)	From screening up to Day 98
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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).
Primary	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).

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Patients With Treatment-Emergent Adverse Events (AEs)	From screening up to Day 98	Safety Population: all randomized participants who received at least one dose of GLPG1690.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	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	Pharmacokinetic (PK) Analysis Set: all randomized participants who received at least one dose of GLPG1690 and for whom evaluable PK data were available. Excludes 1 patient who withdrew because of an AE prior to Week 1 (and had only PK concentrations for baseline and early discontinuation) and 1 patient with only a single predose sample at Week 4	µg/mL	MEAN
PRIMARY	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	PK Analysis Population; excludes 1 patient who withdrew because of an AE prior to Week 1 (and had only PK concentrations for baseline and early discontinuation) and 1 patient with only a single predose sample at Week 4.	hours	MEDIAN
PRIMARY	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	PK Analysis Population; excludes 1 patient who withdrew because of an AE prior to Week 1 (and had only PK concentrations for baseline and early discontinuation) and 1 patient with only a single predose sample at Week 4.	µg.h/mL	MEAN
PRIMARY	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	PK Analysis Population; excludes 1 patient who withdrew because of an AE prior to Week 1 (and had only PK concentrations for baseline and early discontinuation) and 1 patient with only a single predose sample at Week 4.	µg/mL	MEAN
PRIMARY	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)	Pharmacodynamic (PD) Population: all randomized participants who received at least one dose of GLPG1690 and had at least one postbaseline assessment with PD data. Only patients with assessments at both baseline and the pre-specified visit(s) were included in the analysis.	peak area ratio	MEAN
PRIMARY	Mean Peak Area Ratio of LPA C18:2 Species in Bronchoalveolar Lavage Fluid (BALF)	Baseline (Day -1) and Day 84	PD Population; only patients with assessments at both baseline and the pre-specified visit were included in the analysis.	peak area ratio	MEAN

Source ClinicalTrials.gov

Results by group22

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Patients With Treatment-Emergent Adverse Events (AEs)	Placebo QD		4		Participants
Number of Patients With Treatment-Emergent Adverse Events (AEs)	GLPG1690 600 mg QD		11		Participants
Mean Maximum Observed Plasma Concentration (Cmax; Micrograms Per Milliliter [µg/mL]) of GLPG1690	GLPG1690 600 mg QD		6.06	Standard Deviation 4.92	µg/mL
Median Time to Occurrence of GLPG1690 Cmax (Tmax; Hours [h])	GLPG1690 600 mg QD		4	Full Range 1.5 to 6	hours
Mean Area Under the Plasma Concentration-Time Curve (AUC[t]; µg.h/mL) of GLPG1690	GLPG1690 600 mg QD		55.6	Standard Deviation 46.6	µg.h/mL
Mean GLPG1690 Plasma Concentration Observed at Predose (Ctrough; µg/mL)	GLPG1690 600 mg QD		0.624	Standard Deviation 0.846	µg/mL
Mean Peak Area Ratio of Lysophosphatidic Acid (LPA) C18:2 Species in Blood	Placebo QD	Baseline	0.4180	Standard Error 0.1088	peak area ratio
Mean Peak Area Ratio of Lysophosphatidic Acid (LPA) C18:2 Species in Blood	GLPG1690 600 mg QD	Baseline	0.3311	Standard Error 0.0670	peak area ratio
Mean Peak Area Ratio of Lysophosphatidic Acid (LPA) C18:2 Species in Blood	Placebo QD	Day 28	0.3650	Standard Error 0.0895	peak area ratio
Mean Peak Area Ratio of Lysophosphatidic Acid (LPA) C18:2 Species in Blood	GLPG1690 600 mg QD	Day 28	0.1476	Standard Error 0.0380	peak area ratio

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo Once Daily (QD)	6
Overall Study	STARTED	GLPG1690 600 mg QD	17
Overall Study	COMPLETED	Placebo Once Daily (QD)	5
Overall Study	COMPLETED	GLPG1690 600 mg QD	15
Overall Study	NOT COMPLETED	Placebo Once Daily (QD)	1
Overall Study	NOT COMPLETED	GLPG1690 600 mg QD	2

Source ClinicalTrials.gov

Adverse events78

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Lower respiratory tract infection	Infections and infestations	Placebo QD	1	6
other	Lower respiratory tract infection	Infections and infestations	GLPG1690 600 mg QD	2	17
other	Nasopharyngitis	Infections and infestations	Placebo QD	1	6
other	Nasopharyngitis	Infections and infestations	GLPG1690 600 mg QD	2	17
other	Infected cyst	Infections and infestations	Placebo QD	0	6
other	Infected cyst	Infections and infestations	GLPG1690 600 mg QD	1	17
other	Pyelonephritis acute	Infections and infestations	Placebo QD	0	6
other	Pyelonephritis acute	Infections and infestations	GLPG1690 600 mg QD	1	17
other	Respiratory tract infection	Infections and infestations	Placebo QD	0	6
other	Respiratory tract infection	Infections and infestations	GLPG1690 600 mg QD	1	17

1 to 10 of 78Source ClinicalTrials.gov

See all 78 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo QD	0	6
Total, all-cause mortality	GLPG1690 600 mg QD	0	17
Total, other adverse events	Placebo QD	4	6
Total, other adverse events	GLPG1690 600 mg QD	11	17
Total, serious adverse events	Placebo QD	2	6
Total, serious adverse events	GLPG1690 600 mg QD	1	17

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29792287	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
GLPG1690 600 mg QD vs Placebo QD: Number of Patients With Treatment-Emergent Adverse Events (AEs)	Trial comparisons
GLPG1690 600 mg QD vs Placebo QD: deaths from any cause	Trial comparisons
GLPG1690 600 mg QD vs Placebo QD: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02738801

GET https://conductscience.org/api/trials/v1/NCT02738801/results?page=2

API reference For AI assistants