Pharmacokinetic, Safety and Efficacy Study of OMS201 in Subjects Undergoing Retrograde Ureteroscopic Removal of Upper Urinary Tract Stones

Inclusion Criteria: * 18 - 65 years of age. * Subject is undergoing retrograde ureteroscopic removal of renal-collecting system or ureteral stones for which general anesthesia will be used. Exclusion Criteria: * No allergies to any of the individual ingredients in OMS201. * Subject taking a prohibited medication. * Pregnant woman, nursing mother, or woman of child-bearing age unwilling to take contraception for the duration of the study. * Subject who has had a renal transplant, has a single kidney, has compromised renal function, or has evidence of papillary necrosis. * Subject who has evidence of a clinically significant urinary tract infection. * Subject who has a prior history of open or laparoscopic urinary tract surgery, or a history of a ureteral stricture. * Subject who has congenital anomalies that would engender an increased procedural safety risk. * Subject with a history of clinically significant chronic or episodic hypotension. * Subject's physical examination is significantly abnormal for purposes of the study as determined by the Investigator. * Subject's screening laboratory evaluations are not within normal limits AND abnormal results are determined by the Investigator to be clinically significant. * Subject is at risk from anesthesia. * Subject is on chronic diuretic use. * Subject has a present condition or history of any clinically significant medical disorder and is determined by the Investigator to be an unsuitable candidate for receipt of an investigational drug.