NCT02089048

Auranofin PK Following Oral Dose Administration

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Amoebiasis

Interventions

Type	Name	Description
DRUG	Auranofin	Auranofin is a gold-containing chemical salt available as 3mg capsules. Cohort 1 receives 6mg oral dose of auranofin once every 24 hours for 7 days

Timeline

• Start date: 2014-04-02
• Primary completion: 2014-09-09
• Completion: 2015-05-13
• First posted: 2014-03-17
• Last updated: 2017-04-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study