A Study With GLPG1972 in Osteoarthritis Subjects
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 50 - 75 |
| Updated: | 11/25/2017 |
| Start Date: | May 15, 2017 |
| End Date: | October 25, 2017 |
Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Doses of GLPG1972 for 4 Weeks in Subjects With Osteoarthritis
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
