A Study With GLPG1972 in Osteoarthritis Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Osteoarthritis

In brief

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 with Osteoarthritis (OA), administered GLPG1972 or placebo. Per cohort, 10 subjects will be randomized in a 4:1 allocation ratio to active treatment with GLPG1972 or matching placebo. In each cohort, OA subjects will be stratified for age (50- 64 years and 65-75 years) with a minimum of 2 of each sex per age group.

Key facts

Study ID

NCT03311009

Run by

Lakefront Biotherapeutics NV

People needed

30

Starts

2017-05-15

Expected to finish

2017-10-25

Last updated by the study team

2017-11-24

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Covance Daytona Beach — Daytona Beach, Florida, United States

Full record on ClinicalTrials.gov

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