NCT00802217

Oral Civamide Safety, Tolerability First in Human Study

A Phase 1 Open-Label, Single-Dose, Dose Escalation Study in Healthy Subjects to Evaluate the Safety and Pharmacokinetics of Orally Administered Civamide (Zucapsaicin)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Winston Laboratories · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Safety and pharmacokinetic first-time-in-human study of orally administered civamide in healthy subjects.

Detailed description

This is an open-label, non-randomized pharmacokinetic study of two dosage strengths of oral Civamide. The study consists of a Screening Period (Days -21 to Day -2), an Admittance Period, A 4 Day in-house Treatment Period(Days 1-4))and a follow-up Visit on Day 7. Pharmacokinetics will be assessed at specified timepoints relative to dosing on Day 1 during the in-house stay. Subjects will be discharged from the research unit following the 72 hr blood draw. Subjects will return to the research unit on Day 7 for a follow-up safety assessment.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Civamide	5 mg liquid filled softgel capsules
DRUG	Civamide	5 mg x 2 liquid softgel capsules

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-06-01
• Completion: 2009-07-01
• First posted: 2008-12-04
• Last updated: 2011-06-10

Locations

1 site across 1 country: United States