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

• Sponsor: NicOx (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00674856
• Collaborator: (none)
• Enrollment: 32
• Locations: 3
• Arm: 1
• Duration (Months): 5
• Patients Per Site: 10.7
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Renal Failure	Drug: naproxcinod	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 32 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: naproxcinod naproxcinod 750mg(375mg caps x2), administered twice a day.	Drug: naproxcinod; 750mg

Outcome Measures

Primary Outcome Measures

1. To assess differences in the plasma pharmacokinetics profile of naproxcinod and naproxen (total and unbound) between renal impaired patients and healthy subjects. [8 days]

Secondary Outcome Measures

1. To assess differences in the plasma and urinary pharmacokinetic profile of naproxcinod metabolites between renal impaired patients and healthy subjects. [8 days]

2. 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. [8 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1		Orlando	Florida	United States
2		Minneapolis	Minnesota	United States
3		St. Paul	Minnesota	United States

Sponsors and Collaborators

• NicOx

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00674856
• Other Study ID Numbers: HCT 3012-X-106
• First Posted: May 8, 2008
• Last Update Posted: Jan 28, 2009
• Last Verified: Jan 1, 2009

• Additional relevant MeSH terms: Renal Insufficiency; Naproxen-n-butyl nitrate

Study Results

No Results Posted as of Jan 28, 2009