Healthy Volunteers Clinical Trial
Official title:
A Single Center, Double-blind, Placebo-controlled Phase I Single-dose Cross-over Study in Healthy Subjects to Investigate the Inhibitory Effect of CG100649, Celecoxib, Naproxen, and Acetazolamide on the Activity of Cyclooxygenases (COX-1, COX-2) and Carbonic Anhydrases (CA-I, CA-II)
Cyclooxygenase-2 (COX-2) inhibitors have become a common analgesic treatment option for
patients with arthritis. However, long-term treatment has been associated with increased
cardiovascular risk. With the past withdrawals and rejections of approval for COX-2
inhibitors the treatment options are now very limited.
This translates for example to about 10 million osteoarthritis patients in the US who cannot
receive COX-2 inhibitors because of concomitant hypertension. And this exemplifies the unmet
medical need to develop and offer safe treatment options for this particular patient
population.
This trial investigates pharmacodynamic aspects of CG100649 which is being developed as a
novel COX-2 inhibitor. Preclinical data show a dual mechanism of action, which consists of
the inhibition of the two enzymes COX-2 and carbonic anhydrase-I/-II (CA-I/II) and through
which the cardiovascular risk of COX-2 inhibition might be attenuated.
Part 1 and 2 (staged analysis): Single dose of study drugs [celecoxib, placebo] followed by
3 days of blood draws as Period I; then after a wash-out phase, single dose of study drugs
[CG100649 2mg and 8mg, celecoxib 200mg, placebo], followed by blood draws on 6 days and
bi-weekly urine collections for 8 weeks.
Part 3: Five-way cross-over of single doses of study drugs with a CG100649 single dose level
as determined by part 1 and 2, celecoxib 200mg, naproxen 500mg, acetazolamide 250mg and
placebo.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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