Clinical trial NCT03311009 (phase 1, status: completed)
Conditions: osteoarthritis
ICD codes: M15.4, M15.0, M16.9, M17.9, M19.011, M19.012, M19.019
Drugs: glpg1972 cohort 1, glpg1972 cohort 2, glpg1972 cohort 3, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects of non-childbearing potential, 50-75 years of age on the date
             of signing the Informed Consent Form (ICF), inclusive extremes.

          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:

          1. Administration of intraarticular glucocorticoid injections or hyaluronan injections in
             the last 3 months prior to study screening.

          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