Status:
COMPLETED
A Study With GLPG1972 in Osteoarthritis Subjects
Lead Sponsor:
Galapagos NV
Conditions:
Osteoarthritis
Eligibility:
All Genders
50-75 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blind, placebo-controlled, stratified, ascending dose, single center study, in three semi-sequential cohorts of 10 male and female subjects of nonchildbearing potential wi...
Eligibility Criteria
Inclusion
- 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.
- Diagnosis of OA (knee and/or hip) made by their physician based on symptoms, clinical signs and documented historical imaging evidence.
- A body mass index (BMI) between 18.0 and 34.9 kg/m2, inclusive extremes.
- 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.
- Subjects with a stable chronic illness at least 3 months will be accepted subject to the investigator's judgment.
Exclusion
- Administration of intraarticular glucocorticoid injections or hyaluronan injections in the last 3 months prior to study screening.
- 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).
- Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
- Positive serology for HBsAg or HCV antibody or history of hepatitis from any cause with the exception of hepatitis A.
- History of or a current immunosuppressive condition.
- Clinically significant serious, per investigator's discretion, and/or unstable illness in the 3 months before screening
- Renal function with an estimated creatinine clearance \< 60 mL/min based on the Cockcroft-Gault formula. Retesting is allowed once (see Section 5.2).
- Use of verapamil, diltiazem, amitriptyline, warfarin, acenocoumarol, phenobarbital and phenytoin, within 4 weeks before first study drug administration
- 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.
- History of solid organ or hematopoietic cell transplantation.
- History of malignancy within the past 5 years.
- 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).
- Significant blood loss (including blood donation \[\> 450 mL\]), or transfusion of any blood product within 12 weeks prior to screening
Key Trial Info
Start Date :
May 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03311009
Start Date
May 15 2017
End Date
October 25 2017
Last Update
November 24 2017
Active Locations (1)
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1
Covance Daytona Beach
Daytona Beach, Florida, United States, 32117