Clinical Trial: Auranofin PK Following Oral Dose Administration

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open Label, Multiple Dose Study to Evaluate the Pharmacokinetics of Auranofin Following Oral Dose Administration for 7 Days to Healthy Subjects

Brief Summary: Phase I, open-label study in 15 healthy adult subjects receive 6 mg of auranofin orally once every 24 hours for 7days. Blood samples will be taken for 17 weeks following the last dose of auranofin for determination of terminal phase pharmacokinetic parameters. Stool samples will also be obtained for the measurement of gold.

Detailed Summary: Auranofin is a gold-containing chemical salt, granted as an orphan drug status for use in the treatment of amebiasis. Amebiasis is a parasitic infection caused by the protozoon Entamoeba histolytica. It affects about ten percent of the world's population, being especially common in areas with poor health infrastructure. This is a Phase I open label, multiple dose study to evaluate the pharmacokinetics of Auranofin following oral dose administration for 7 days to healthy subjects. 15 healthy male and female volunteers age 18-45 years, inclusive enrolled in one site. The study duration is 48 weeks and up to 23 weeks of subject participation. The primary objective characterizes the pharmacokinetics of gold, given as auranofin, during and after 7 days of once daily oral dose administration. The secondary objective monitor the safety of Auranofin during and after 7 days of oral administration.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome: Plasma concentrations of gold following 7 once daily doses of auranofin [ Time Frame: Up to Day 126 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Type, frequency and severity of Serious AEs (SAEs) to the end of study [ Time Frame: Up to Day 126 ]
  • Type, frequency and severity of treatment-emergent adverse events (TEAEs) to 14 days after administration of the first dose [ Time Frame: 14 Days after first dose ]


Original Secondary Outcome:

  • Type, frequency and severity of treatment-emergent adverse events (TEAEs) to 14 days after administration of the first dose [ Time Frame: 14 Days after first dose ]
  • Type, frequency and severity of Serious AEs (SAEs) to the end of study [ Time Frame: Up to Day 126 ]


Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: March 13, 2014
Date Started: April 2, 2014
Date Completion:
Last Updated: April 27, 2017
Last Verified: March 12, 2014