Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2017-05-15
2017-10-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GLPG1972
GLPG1972 cohort 1
GLPG1972 dose 1 provided as oral tablets q.d.
GLPG1972 cohort 2
GLPG1972 dose 2 provided as oral tablets q.d.
GLPG1972 cohort 3
GLPG1972 dose 3 provided as oral tablets q.d.
Placebo
Placebo
Matching placebo provided as oral tablets q.d.
Interventions
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GLPG1972 cohort 1
GLPG1972 dose 1 provided as oral tablets q.d.
GLPG1972 cohort 2
GLPG1972 dose 2 provided as oral tablets q.d.
GLPG1972 cohort 3
GLPG1972 dose 3 provided as oral tablets q.d.
Placebo
Matching placebo provided as oral tablets q.d.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of OA (knee and/or hip) made by their physician based on symptoms, clinical signs and documented historical imaging evidence.
3. A body mass index (BMI) between 18.0 and 34.9 kg/m2, inclusive extremes.
4. Judged to be in age-appropriate good health by the investigator based upon the results of a medical history, physical examination, vital signs and 12-lead ECG, and fasting clinical laboratory profile.
5. Subjects with a stable chronic illness at least 3 months will be accepted subject to the investigator's judgment.
Exclusion Criteria
2. Subjects who underwent or are on a waiting list for total hip or knee replacement and any other surgery planned during the study (up to Day 50).
3. Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
4. Positive serology for HBsAg or HCV antibody or history of hepatitis from any cause with the exception of hepatitis A.
5. History of or a current immunosuppressive condition.
6. Clinically significant serious, per investigator's discretion, and/or unstable illness in the 3 months before screening
7. Renal function with an estimated creatinine clearance \< 60 mL/min based on the Cockcroft-Gault formula. Retesting is allowed once (see Section 5.2).
8. Use of verapamil, diltiazem, amitriptyline, warfarin, acenocoumarol, phenobarbital and phenytoin, within 4 weeks before first study drug administration
9. Consumption of herbal medications that are strong inhibitors and/or inducers of CYPs (e.g., St. John's Wort) and grapefruit/grapefruit products, Seville oranges, or any poppy seed, within 7 days prior to the first study drug administration.
10. History of solid organ or hematopoietic cell transplantation.
11. History of malignancy within the past 5 years.
12. Clinically significant abnormalities detected on 12-lead ECG of either rhythm or conduction (e.g., QTcF ≥ 450 ms for males and QTcF ≥ 470 ms for females, or a known long QT syndrome).
13. Significant blood loss (including blood donation \[\> 450 mL\]), or transfusion of any blood product within 12 weeks prior to screening
50 Years
75 Years
ALL
No
Sponsors
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Galapagos NV
INDUSTRY
Responsible Party
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Principal Investigators
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Ann Fieuw, MD, MSc
Role: STUDY_DIRECTOR
Galapagos NV
Locations
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Covance Daytona Beach
Daytona Beach, Florida, United States
Countries
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References
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Chen L, Huang FL, Tang Q, Zhao ZK, Ye ZY, Liang JH. Targeted therapy for knee osteoarthritis: From basic to clinics. Medicine (Baltimore). 2025 Aug 15;104(33):e43686. doi: 10.1097/MD.0000000000043686.
Other Identifiers
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GLPG1972-CL-104
Identifier Type: -
Identifier Source: org_study_id