NCT01404598

Pharmacokinetics Study: Determination of Naproxcinod and Its Metabolites After Oral Administration in Male

A Phase 1 Study to Assess the Pharmacokinetics of Nitrates and Gamma-Hydroxybutyric Acid (GHB) After Oral Administration of Therapeutic and Supratherapeutic Doses of Naproxcinod in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: NicOx · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will be performed in 2 parts conducted in parallel: Part 1 (conducted on 16 healthy subjects): Administration of naproxcinod 750 mg or naproxen 500 mg twice a day (bid) during 7 days The main aim of this study part will be to assess the pharmacokinetic profile (i.e. the absorption, the distribution, the metabolism and the elimination of the drug after its administration) of nitrates (metabolite of naproxcinod) present in plasma, saliva and urine after oral administration of naproxcinod 750 mg bid for 7 days or naproxen 500 mg bid for 7 days as a reference. Part 2 (conducted on 8 healthy subjects): Administration of a single dose of naproxcinod 3000 mg. The main aim of this study part will be to assess the pharmacokinetic profile (i.e. the absorption, the distribution, the metabolism and the elimination of the drug after its administration) of Gamma-Hydroxybutyric Acid (GHB), a compound resulting from the transformation of the naproxcinod, after oral administration of a single supratherapeutic dose of 3000 mg.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	naproxcinod 750 bid	naproxcinod 750 bid
DRUG	naproxcinod 3000 mg od	naproxcinod 3000 mg od
DRUG	naproxen 500 mg bid	naproxen 500 mg bid

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2011-07-28
• Last updated: 2011-08-11