A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function (HCT3012-X-106)

This study has been completed.

Sponsor:

Information provided by:

NicOx

ClinicalTrials.gov Identifier:

NCT00674856

First received: May 6, 2008

Last updated: January 27, 2009

Last verified: January 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	May 6, 2008
Last Updated Date	January 27, 2009
Start Date ^ICMJE	May 2008
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 7, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00674856 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 7, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function
Official Title ^ICMJE	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
Brief Summary	To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal function
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Renal Failure
Intervention ^ICMJE	Drug: naproxcinod 750mg
Study Arm (s)	Experimental: naproxcinod naproxcinod 750mg(375mg caps x2), administered twice a day. Intervention: Drug: naproxcinod
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	32
Completion Date	October 2008
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00674856
Other Study ID Numbers ^ICMJE	HCT 3012-X-106
Has Data Monitoring Committee	Yes
Responsible Party	NicOx, NicOx.
Study Sponsor ^ICMJE	NicOx
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NicOx
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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