Pharmacokinetic and Safety Study of OMS201 in Subjects Undergoing Ureteroscopic Treatment for Removal of Urinary Tract-Located Stones

NCT00599664 | Completed Phase 1

• 1 other identifier: C07-001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

Evaluate the safety and systemic absorption of OMS201 following exposure during ureteroscopy.

Conditions

Urinary Calculi; Urinary Stones; Urinary Tract Stones

Keywords

Urinary Calculi; Urinary Stones; Urinary Tract Stones; Calculi

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic

  Day of Surgery

Secondary Outcomes (1)

• Safety

  Day 7

Study Arms (2)

1

EXPERIMENTAL

Drug

Drug: OMS201

2

PLACEBO COMPARATOR

Vehicle

Drug: Vehicle

Interventions

OMS201 DRUG

OMS201 irrigation solution during surgery

1

Vehicle DRUG

Vehicle irrigation solution during surgery

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is undergoing unilateral ureteroscopic removal of renal collecting system or ureteral stones located in the ureter with a maximum stone diameter of 12 mm, for which general anesthesia will be used.
• Subject's physical examination is within normal limits or examination is clinically non-significant for purposes of the study as determined by the Investigator, and subject is in good general health.
• Subject's laboratory evaluations are within normal limits or evaluations are clinically non-significant as determined by the Investigator.
• Female subject of childbearing potential who is using an effective method of birth control within at least 14 days prior to surgery and has a negative pregnancy test.
• Subject is at minimal risk from anesthesia and is classified according to the American Society of Anesthesiologists Physical Status Classification as either PS-1 or PS-2.
• Subject's body mass index is between 19 and 35, inclusive, based on the Body Mass Index Table.

You may not qualify if:

• Subject taking a prohibited medication.
• Subject who has had a renal transplant, has a single kidney or has evidence of a compromised renal function as measured by abnormal serum creatinine, as judged by the Investigator, or who has evidence of urinary tract infection, or has prior history of open or laparoscopic surgery, or any history of an ureteral stricture.
• Subject who has congenital anomalies that would engender an increased procedural safety risk such as ureteropelvic junction obstruction resulting in severely dilated renal pelvis, duplicated urinary collecting system, horseshoe kidney or vascular anomalies such as renal arteriovenous fistulas or papillary necrosis.
• Subject has bilateral renal or ureteral stones requiring concurrent ureteroscopic removal.
• Subject with clinically significant hypotension at Screening.
• Subject who has a present condition or history of any clinically significant uncontrolled gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, connective tissue, respiratory or other medical disorder as determined by the Investigator.
• Subject on chronic diuretic use.
• Subject who has taken or used an investigational drug or device within 30 days prior to the day of surgery.

Sponsors & Collaborators

• Omeros Corporation: lead

Study Sites (2)

UC Irvine Medical Center

Orange, California, 92868, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Urinary Calculi; Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott Houston

  Omeros Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 24, 2008
• Study Start: December 1, 2007
• Study Completion: September 1, 2008
• Last Updated: April 30, 2010

Record last verified: 2010-04

Locations

US (2)