A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function - Full Text View

Purpose

To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal function

Condition	Intervention	Phase
Renal Failure	Drug: naproxcinod	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study

Official Title:	A Phase 1 Repeated Dose Open Label Study to Investigate the Pharmacokinetics and Safety of Naproxcinod 750mg Bid Administered to Patients With Impaired Renal Function Compared to Matching Healthy Subjects

Further study details as provided by NicOx:

Primary Outcome Measures:

To assess differences in the plasma pharmacokinetics profile of naproxcinod and naproxen (total and unbound) between renal impaired patients and healthy subjects. [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess differences in the plasma and urinary pharmacokinetic profile of naproxcinod metabolites between renal impaired patients and healthy subjects. [ Time Frame: 8 days ] [ Designated as safety issue: No ]
To assess the general safety of naproxcinod in renal impaired patients and in healthy subjects as shown by the biological tolerance and the adverse events (AE) profile. [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	32
Study Start Date:	May 2008
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
naproxcinod: Experimental naproxcinod 750mg(375mg caps x2), administered twice a day.	Drug: naproxcinod 750mg

Detailed Description:

This is an 8-day, repeated dose, open label study to investigate the pharmacokinetics and safety of naproxcinod in order to guide initial dosing and achieve the optimal dose of naproxcinod in Renal impaired patients.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female aged 18 to 75 years with stable mild to moderate renal insufficiency.
Male or female aged 18 to 75 years with similar distribution of age, weight, gender, smoking habits, and race, and in general good health

Exclusion Criteria:

Any significant acute or chronic disease (except renal impairment) which may interfere with study evaluations.
A history of alcohol or drug abuse.
Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding within the last 6 months
Clinically relevant abnormal ECG
Current or expected use of anticoagulants or analgesic, anti-inflammatory therapies except low dose aspirin (less than or equal to 325mg per day).
Participation within 30 days prior to screening in another investigational study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674856

Locations


United States, Florida
		Recruiting
	Orlando, Florida, United States
	Contact: Site Contact Number 407-472-0227

United States, Minnesota
		Recruiting
	Minneapolis, Minnesota, United States
	Contact: Site Contact Number 612-618-1002
		Recruiting
	St. Paul, Minnesota, United States
	Contact: Site Contact Number 651-641-2924

Sponsors and Collaborators

NicOx

More Information

Responsible Party:	NicOx. ( NicOx )
Study ID Numbers:	HCT 3012-X-106
First Received:	May 6, 2008
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00674856
Health Authority:	United States: Food and Drug Administration