A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function

Renal Failure Clinical Trial

— HCT3012-X-106  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674856
• Other study ID #: HCT 3012-X-106
• Status: Completed
• Phase: Phase 1
• First received: May 6, 2008
• Last updated: January 27, 2009
• Start date: May 2008
• Est. completion date: October 2008

Study information

• Verified date: January 2009
• Source: NicOx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• naproxcinod
750mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NicOx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess differences in the plasma pharmacokinetics profile of naproxcinod and naproxen (total and unbound) between renal impaired patients and healthy subjects.		8 days	No
Secondary	To assess differences in the plasma and urinary pharmacokinetic profile of naproxcinod metabolites between renal impaired patients and healthy subjects.		8 days	No
Secondary	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	Yes