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Completed

NCT Number: NCT00674856

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

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

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Key information

Conditions

Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orlando, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naproxcinod

Drug

750mg

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 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.

    Time frame: 8 days

Sponsors and collaborators

Lead sponsor

NicOx

Industry

Registry information

Official study 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

Acronym: HCT3012-X-106

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 8, 2008
Registry last updated
Jan 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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