Publications, Nonclient Clinical Trial Experience, & Presentations

Publications

Rapid and reversible modulation of platelet function in man by a novel P2Y12 ADP-receptor antagonist, INS50589

FL Johnson, JL Boyer, PT Leese, C Crean, R Krishnamoorthy, T Durham, AW Fox, DJ Kellerman
Platelets, August 2007; 18(5): 346-356

In Vivo Profile of ICA-27243 [N-(6-Chloro-pyridin-3-yl)-3,4-difluoro-benzamide], a Potent and Selective KCNQ2/Q3 (Kv7.2/Kv7.3) Activator in Rodent Anticonvulsant Models

R Roeloffs, A Wickenden, C Crean, S Werness, G McNaughton-Smith, J Stables, J McNamara, N Ghodadra and G Rigdon
JPET 2008, vol 326, 818-828 doi: 10.1124/jpet.108.137794

Ocular Surface Distribution and Pharmacokinetics of a Novel Ophthalmic 1% Azithromycin Formulation

E K Akpek, J Vittitow, R S Verhoeven, T Amar, K Powell J L Boyer, C Crean
J Ocular Pharmacol and Ther. 2009 Oct;25(5):433-9 doi: 10.1089/jop.2009.0026

Systemic peripheral artery relaxation by KCNQ channel openers and hydrogen sulfide

Schleifenbaum J, Kohn C, Voblova N, Dubrovska G, Zavarirskaya O, Gloe T, Crean CS, Luft FC, Huang Y, Shcubert R, Gollasch M.
J Hypertens. 2010 Sep; 28(9): 1875-82 doi: 10.1097/HJH.0b013e32833c20d5. PMID: 20577128

Pharmacokinetics of Azithromycin and moxifloxacin in Human Conjunctiva and Aqueous Humor During and After the approved Dosing Regimens

Stewart WC, Crean CS, Kink RC, Brubaker K, Haque RM, Hwang DG
Am J Ophthalmol. 2010 Nov; 150(5):744-751 doi: 10.1016/j.ajo. 2010.05.039. PMID: 20813346

The spectrum of anticonvulsant efficacy of retigabine (ezogabine) in animal models: implications for clinical use

Large CH, Sokal DM, Nehlig A, Gunthorpe MJ, Sankar R, Crean CS, Vanlandingham KE, White HS
Epilepsia. 2012 Mar;53(3):425-36 doi: 10.1111/j.1528-1167.2011.03364.x. PMID: 22221318

The Effects of Ethanol on the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Ezogabine (Retigabine)

Crean CS, Tompson DJ
Clin Ther. 2013 Jan;35(1):87-93 doi: 10.1016/j.clinthera.2012.12.003 PMID: 23328270

Efficacy and Safety Exposure-Response Relationship of Retigabine (Ezogabine) Immediate-Release Tablets in Patients with Partial-Onset Seizures

Tompson DJ, Crean CS, Reeve R, Berry NS.
Clin Ther. 2013 Aug;35(8):1174-1185 doi: 10.1016/j.clinthera.2013.06.012 PMID: 23916044

Clinical Pharmacokinetics of Retigabine/Ezogabine

Tompson DJ, Crean CS
Curr Clin Pharmacol. 2013 Nov;8(4):319-31 PMID: 23342983

The Interaction Potential of Retigabine (Ezogabine) with other Antiepileptic Drugs

Tompson DJ, Crean CS
Curr Clin Pharmacol. 2014 May;9(2):148-56 PMID: 24219007

The Effect of Ezogabine on the Pharmacokinetics of an Oral Contraceptive Agent

Crean CS, Buraglio M, Tompson DJ
Int J of Clin Pharm and Thera. 2013 Nov;51(11) 847-53 doi:10.5414/CP201916 PMID: 24040852

The Effect of Hemodialysis on the Pharmacokinetics of Ezogabine/Retigabine and its N-Acetyl Metabolite: Results of a Phase I Study

Tompson DJ, Buraglio M, Bullman J, Crean CS, Rayner K
Curr Clin Pharmacol. Vol. 9, No. 4, 2014:p319-325

Lack of Effect of Ezogabine/Retigabine on the Pharmacokinetics of Digoxin in Healthy Individuals: Results from a Drug–Drug Interaction Study

DJ Tompson, Crean CS, Buraglio M, Arumugham T.
Clin Pharm: Advances and Applications Oct; (vol 6) 2014; p149-159 http://dx.doi.org/10.2147/CPAA.S64131

Single-Dose Pharmacokinetics of Bupropion Hydrobromide and Metabolites in Healthy Adolescent and Adult Subjects

Oh DA, Crean CS.
Clin Pharm in Drug Development. Vol. 4, (5), 2015:p 346–353 DOI: 10.1002/cpdd.195

Sustained Treatment of Retinal Vascular Diseases with Self-Aggregating Sunitinib Microparticles

Tsujinaka H, et al.
Nature Communications. 2020 Feb 4;11(1):694

Discovery and validation of biomarkers to aid the development of safe and effective pain therapeutics: challenges and opportunities

Davis KD, Aghaeepour N, et al.
Nature Reviews Neurology 2020 Jun 15 https://doi.org/10.1038/s41582-020-0362-2

Engineered controlled drug delivery without polymers: Sustained delivery implants formed solely of low molecular weight corticosteroid dimers

Parrag I, et al.
Nature Communications. Under review.

Nonauthor contributing scientist

Conjunctival tissue pharmacokinetic properties of topical axithromycin 1% and moxifloxacin 0.5% ophthalmic solutions: a single-dose, randomized, open-label, active controlled trial in healthy adult volunteers

G Torkildsen, T O’Brien
Clin Ther. 2008 Nov;30(11):2005-14

The mechanism of action of retigabine (ezogabine), a first-in-class K+ channel opener for the treatment of epilepsy

MJ Gunthorpe, CH Large, R Sankar
Epilepsia. 2012 Mar;53(3):412-24

Investigation of the impact of urine handling procedures on interpretation of urinalysis findings and product safety in subjects treated with ezogabine.

Brickel N, Derossett S, Buraglio M, Evans C, Jones S.
Ther Clin Risk Manag. 2013;9:207-13. doi: 10.2147/TCRM.S42536.

A novel design for a dose finding, safety, and drug interaction study of an antiepileptic drug (retigabine) in early clinical development

R Sachdeo, A Partiot, V Biton, WE Rosenfeld, V Nohria, D Tompson, S DeRossett, and RJ Porter.
Inter. J Clin Pharm and Ther. (epub) doi: 10.5414/CP202081

Human mass balance study of TAS-102 using (14)C analyzed by accelerator mass spectrometry

Lee JJ, Seraj J, Yoshida K, et al.
Cancer Chemother Pharmacol. 2016 Mar:77(3):515-26

Non-client clinical trial experience

I have designed and overseen multiple clinical pharmacology/biopharmaceutics studies in support of product transfer and prior approval supplement submissions. In addition, I’ve contributed as a team member in design, initiation or completion of following ClinicalTrials.gov listed trials.

Invited Public Presentations

Epilepsy Foundation, Pipeline Conference, San Francisco, USA, February 25-26, 2106: 1OP-2198
EILAT XIII, Madrid, Spain, June 26-29, 2016: 1OP-2198, a Selective Kv7 Potassium Channel Opener
KCNQ2 Cure Summit Meeting, Silver Springs, Maryland, October 7-9, 2016: Early Infantile Epileptic Encephalopathy 7 (EIEE7 or KCNQ2 Encephalopathy) and 1OP-2198

Conference or Congress Poster Presentations

Christopher S. Crean and Stephen Werness “A New Method for the Rapid Analysis of Compounds from Brain Tissue and Plasma to Determine Brain Penetration by Turbulent Flow Chromatography Tandem Mass Spectrometry” ASMS Conference on Mass Spectrometry and Allied Topics, 2001
Christopher S. Crean, J. Douglass, B. Yerxa, K. Redick, R. Patel and A. Jones “Dinucleoside Tetraphosphates with Base Lipophilic Substituent Modifications: Selected Structure-Activity Relationships at Nucleotide G-Protein Coupled Receptors” IUPHAR, 2002
Christopher S. Crean, BR Yerxa, K Bednarski and WM Peterson “Analgesic Effects of INS48506, A P2X3 Receptor Antagonist, in Models of Acute, Inflammatory and Neuropathic Pain” Neuroscience, 2003
Christopher S. Crean, W Eckert, J Howard, G Pollard, M Boncek, L Lan, T Durham, W Peterson “Nociceptive Activity/Agitation Behavioral Responses in Rats: A Novel Objective Assay” Neuroscience, 2004
Christopher S. Crean, Arthur P. Bode, You-Su Sun, Wiley Nifong, Matt Cowlen, Stephanie Anderson, Ward Peterson, José L. Boyer “Antiplatelet Treatment with P2Y12 Receptor Antagonist Decreases Blood Loss in a Canine CABG Model with Cardiopulmonary Bypass” J Am Coll Cardiol 2006, 47(4 Suppl A) 191A
Christopher S. Crean, José L. Boyer. The Disposition, Metabolism and Elimination of INS50589, a Potent, Selective and Reversible P2Y12 Receptor Antagonist in Rats. ISSX (June, 2006)
H Liang, J Zhao, C Nguyen, L Tang, Y Zhu, YS Chen, B Chien, Christopher S. Crean. Determination of INS115644 in Rabbit Plasma by LC/MS/MS. CosMos (July, 2006)
C Crean, D McLaverty, A Sologuren, R Valeinte. Effect of grapefruit juice on the pharmacokinetics of Bilastine. ACCP Annual Mtg September 9-11, 2007 San Francisco, CA
C Crean, P Ratner, M Widmann, A Schaberg, D Kellerman. Pharmacokinetic Model of Epinastine, an H1 Antagonist, after Nasal Administration. AAAAI March 14-18, 2008, Philadelphia, PA
C Crean, J Vittitow, R Zink, L Richards, R Verhoeven, K Powell, K Brazzell. Ocular Pharmacokinetics of 1% Azasite, a novel antibiotic formulation for Bacterial Conjunctivitis. ASCRS April 4-9 2008, Chicago, IL.
C Crean, SJ Godin, M Cowlen, D Kellerman. Pharmacokinetics of Denufosol: Results from Preclinical Studies. NACFC October 23-25 2008, Orlando FL.
C. Crean, S. Hall. A Novel and Potent Kv7.2/7.3 Opener with Demonstrated preclinical Safety and Anti-Convulsant Properties. EILAT X April 25-29, 2010 Eilat, Israel
Debra J Tompson, Christopher S. Crean, Kevan E VanLandingham. The Effects of Food on Ezogabine (Retigabine). AAN April 9-16, 2011, Honolulu, Hawaii
Christopher S. Crean, Debra J Tompson, Kevan E VanLandingham. The Effects of Ethanol on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ezogabine (Retigabine). AAN April 9-16, 2011, Honolulu, Hawaii
D. Alexander Oh, Mary Barecki-Roach, Jonathan Stocker, Christopher S. Crean. Normalization and Comparative Statistical Analysis on Exposures of Bupropion and its Metabolites for Adult and Adolescent Subjects after a Single Oral Dose of Aplenzin. ACCP Sept 23-25, 2012, San Diego, CA
Crean C, Kang R, Oh A. Aoyama A. Minimal Systemic Exposure of a new topical Triazole Antifungal, Efinaconazole 10% Solution, in Patients with Severe Onychomycosis Following 28-Day Treatment. ADD Mar 1-5, 2013, Miami Beach, FL.
Christopher Crean, Mauro Buraglio, Debra Tompson, James Storey, Thangam Arumugham. Multiple pharmacokinetic assessments of five unique formulations of ezogabine/retigabine compared with the immediate release formulation. SCT May19-22, 2013, Boston, MA
Christopher S. Crean, Debra J. Tompson, Mauro Buraglio, Kirsty S. Rayner. Effect of hemodialysis on the pharmacokinetics of ezogabine/retigabine and its N-acetyl metabolite: results of an open-label, single-dose, fixed-sequence phase 1 study. IEC, June 23-27, 2013, Montreal, Quebec, Canada
Christopher Crean, Debra Tompson, Mauro Buraglio. Effects of ezogabine/retigabine on the pharmacokinetics of digoxin in healthy individuals: results from a drug-drug interaction study. IEC, June 23-27, Montreal, Quebec, Canada
Leo Trevino, Tomas Navratil, RiLee Robeson, Andres Garcia, Janet Tully, Michael Hunter, Daria Stoltz, Ben Maynor, Rozemarijn Verhoeven, Kendall Powell, Christopher Crean, Brian C. Gilger, Benjamin Yerxa. Intracameral Conversion of Travoprost to Travoprost Acid in the Normotensive Beagle Dog Model. ARVO, May 4-7, Orlando, FL. LINK
Beatch GN, Rosenblut CL, Evans, S, Namdari R, Cadieux J, Tandy M, Harden C, Crean CS, Pimstone, S, Aycardi E, Loewen G. XEN901. Eilat XV, Madrid, Spain
Parrag I, Louka D. et al. “Ocular pharmacokinetics, pharmacodynamics, and safety analysis of a novel dexamethasone intravitreal implant” ARVO 2020 Video presentation.