NCT00619346

Randomized, Double-Blind Phase 1 Safety and Tolerability Study of Pafuramidine Maleate (DB289) in Healthy Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Immtech Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1 study to establish the safety and tolerability profile of pafuramidine maleate 100 mg BID administered orally for 14 days to healthy subjects

Detailed description

This is a Phase 1, randomized, double-blind, placebo-controlled, parallel treatment single center safety and tolerability study. Subjects who meet all inclusion criteria and none of the exclusion criteria will be randomized in a 4:1 fashion to receive either pafuramidine maleate 100 mg tablets or matching placebo tablets administered twice daily for 14 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Placebo	Placebo tablets, BID X 14 days
DRUG	pafuramidine maleate	Pafuramidine maleate, 100 mg tablet BID X 14 days

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-02-20
• Last updated: 2013-03-07

Locations

1 site across 1 country: South Africa