NCT02205554

Omnitram Pharmacokinetic Study In Healthy Volunteers

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Triple Cross-Over Study Investigating The Safety, Oral Steady-State Pharmacokinetics, And Clinical Activity Of 20 Mg Omnitram And 50 Mg Tramadol In Normal Human Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Syntrix Biosystems, Inc. · Industry
• Sex: Male
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the safety, pharmacokinetic properties (the absorption, distribution and excretion), and analgesic activity of Omnitram (10 mg tablets), Tramadol (Ultram, 50 mg tablet) following oral administration of 9 doses healthy subjects.

Detailed description

A Phase 1, single-center, randomized, double-blind, placebo-controlled, three-period cross-over study to compare the safety, steady-state oral pharmacokinetics, and clinical activity of overencapsulated: 20 mg Omnitram (2x10 mg tablets), 50 mg Tramadol (1x50 mg Ultram tablet), and placebo. Forty male subjects in normal health, 21 to 55 years of age, will be randomized to three parallel arms (N=\~13 each) to ingest a total of 9 doses of Omnitram, Tramadol, or placebo in a first treatment segment (one dose every 6 hours). Around the 9th dose blood samples are collected to quantify plasma Tramadol and Metabolite 1 (M1) enantiomers. After the 9th dose, pain tolerance is assessed with a cold pressor test (ice cold water immersion). After the 7th dose abuse liability measures and pupil diameter will be assessed. Subjects will washout for 7 days after the first treatment segment and second treatment segment.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Omnitram	Nine 20 mg doses administered every 6 hours
DRUG	Tramadol	Nine 50 mg doses administered every 6 hours.
DRUG	Placebo	Nine doses administered every 6 hours.

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-07-31
• Last updated: 2014-10-15

Locations

1 site across 1 country: United States