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.