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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738801
• Other study ID #: GLPG1690-CL-202
• Secondary ID: 2015-004157-41
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: May 2, 2017

Study information

• Verified date: October 2020
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multicenter randomized, double-blind, parallel group, placebo-controlled, exploratory phase IIa study in subjects with Idiopathic Pulmonary Fibrosis (IPF) to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GLPG1690. Male and female subjects aged 40 years or older will be screened to determine eligibility. The screening period will be up to 4 weeks. At baseline, eligible subjects will be randomized in a 3:1 ratio to GLPG1690 or matching placebo administered for 12 weeks. The subjects will visit the study center at screening, baseline, Weeks 1, 2, 4, 8 and 12 and for a follow-up visit 2 weeks after the last administration of study drug. Planned assessments: Adverse event reporting, clinical laboratory tests, vital signs, physical examination, 12-Lead-ECG, PK blood sampling, biomarker blood/bronchoalveolar lavage fluid (BALF), Spirometry, St George's respiratory questionnaire, high-resolution computed tomography (HRCT).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2, 2017
• Est. primary completion date: May 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Subjects able and willing to sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF)

2. Male or female subjects of non-child-bearing potential aged = 40 years

3. Subjects with a chest HRCT performed within 12 months prior to screening

4. Subjects with IPF diagnosed by a multidisciplinary team

5. Subjects with: a. forced vital capacity (FVC) =50% predicted of normal AND b. Diffusing capacity for the lungs for carbon monoxide (DLCO) = 30% predicted of normal corrected for hemoglobin

6. Subjects with a forced expiratory volume in 1 second (FEV1)/FVC (Tiffeneau-Pinelli index) ratio = 0.70 (based on pre-bronchodilator spirometry

7. Subjects on stable supportive care

8. Subjects in stable condition

Exclusion Criteria:

1. Subjects with know hypersensitivity to any of the study drug ingredients

2. Subjects with a history of or current immunosuppressive condition

3. Subjects with a history of malignancy within the past 5 years

4. Subjects with clinically significant abnormalities on ECG

5. Subjects with acute IPF exacerbation within 6 weeks prior to screening

6. Subjects with a lower respiratory tract infection requiring antibiotics with 4 weeks prior to screening

7. Smoking within 3 months pre-screening

8. Interstitial lung disease

9. History of lung volume reduction surgery or lung transplant

10. Unstable cardiac or pulmonary disease other than IPF within 6 months prior to screening

11. Subjects with abnormal liver function

12. Subjects with abnormal renal function

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• GLPG1690 600 mg QD
GLPG1690 capsules, administered at a dose of 600 mg, orally QD
• Placebo QD
Matching placebo capsules, administered orally QD

Locations

Country	Name	City	State
Ukraine	Municipal Clinical Hospital # 6	Dnipropetrovsk
Ukraine	Kharkov City Clinical Hospital # 13	Kharkov
Ukraine	F.G. Yanovskyy Institute of Phthisiatry and Pulmonology 1	Kiev
Ukraine	F.G. Yanovskyy Institute of Phthisiatry and Pulmonology 2	Kiev
Ukraine	Oesa Regional Clinical Hospital	Odesa
Ukraine	Poltava Regional Clinical Antituberculosis Dispancery	Poltava
United Kingdom	Royal Brompton Hospital	London
United Kingdom	The Medicines Evaluation Unit	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Countries where clinical trial is conducted

Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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).	Baseline (Day -1), predose and 1.5 and 6 hours postdose on Day 28, predose on Day 84, and Day 98 (or early discontinuation)
Primary	Mean Peak Area Ratio of LPA C18:2 Species in Bronchoalveolar Lavage Fluid (BALF)	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).	Baseline (Day -1) and Day 84