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Sponsors and Collaborators: |
University of Pennsylvania CrystalGenomics, Inc. |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00780325 |
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.
Condition | Intervention | Phase |
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Healthy Volunteers |
Drug: CG100649 (2 mg) Drug: Celecoxib Drug: Placebo capsules Drug: Naproxen Drug: Acetazolamide Drug: CG100649 (8 mg) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study |
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) |
Estimated Enrollment: | 49 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
CG100649, single oral dose of 2 mg
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Drug: CG100649 (2 mg)
CG100649 capsules: 2 mg, single oral administration (Part 1); CG100649 capsules: dose to be determined, single oral administration (the single CG100649 dose level used in Part 3 will be determined by part 1 and 2).
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2: Experimental
CG100649, single oral dose of 8 mg
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Drug: CG100649 (8 mg)
CG100649 capsules: 8 mg, single oral administration (Part 1); CG100649 capsules: dose to be determined, single oral administration (the single CG100649 dose level used in Part 3 will be determined by part 1 and 2).
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3: Active Comparator
Celecoxib, single oral dose of 200 mg
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Drug: Celecoxib
Celecoxib (Celebrex®) capsules: 200 mg; single oral administration (Part 1 and 3)
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4: Active Comparator
Naproxen, single oral dose of 500 mg
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Drug: Naproxen
Naproxen (Naprosyn®) tablets: 500 mg, single oral administration (Part 3)
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5: Active Comparator
Acetazolamide, single oral dose of 250 mg
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Drug: Acetazolamide
Acetazolamide (generic, immediate release) tablets: 250 mg, single oral administration (Part 3)
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6: Placebo Comparator
Placebo, single oral administration
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Drug: Placebo capsules
Placebo capsules: 198 mg silicified microcrystalline cellulose + 2 mg talc, multiple oral administrations (Part 1 and 3)
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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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kristina Alfaro, B.A. | 215-662-4634 | kalfaro@mail.med.upenn.edu |
Contact: Carsten Skarke, M.D. | 215.898.9006 | cskarke@mail.med.upenn.edu |
United States, Pennsylvania | |
Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Kristina Alfaro, B.A. 215-662-4634 kalfaro@mail.med.upenn.edu | |
Contact: Carsten Skarke, M.D. 215.898.9006 cskarke@mail.med.upenn.edu | |
Principal Investigator: Garret A FitzGerald, M.D. | |
Principal Investigator: Carsten Skarke, M.D. | |
Sub-Investigator: Naji Alamuddin, MB BCh |
Principal Investigator: | Garret A FitzGerald, MD | Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine |
Principal Investigator: | Carsten C Skarke, MD | Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine |
Study Director: | William K Schmidt, PhD | CrystalGenomics, Inc. |
Responsible Party: | University of Pennsylvania ( Carsten Skarke, Dr. ) |
Study ID Numbers: | 807821 |
Study First Received: | October 24, 2008 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00780325 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Cyclooxygenase-2 Carbonic anhydrase Eicosanoids Healthy volunteers |
Anti-Inflammatory Agents Celecoxib Naproxen Cyclooxygenase Inhibitors Diuretics Acetazolamide Healthy Cardiovascular Agents |
Carbonic Anhydrase Inhibitors Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Anticonvulsants |
Anti-Inflammatory Agents Naproxen Celecoxib Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Diuretics Physiological Effects of Drugs Acetazolamide Enzyme Inhibitors Cardiovascular Agents Gout Suppressants Pharmacologic Actions |
Carbonic Anhydrase Inhibitors Sensory System Agents Analgesics, Non-Narcotic Natriuretic Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Anticonvulsants |