NCT03312777

Omnitram Pharmacokinetic and Analgesic Study Following CY2D6 Inhibition With Paroxetine In Healthy Volunteers

A Phase 1b, Double-Blind, Randomized, Placebo-Controlled, Three Segment Cross-Over Study Investigating Oral Steady-State Pharmacokinetics And Hypoalgesic Effect Of 20 Mg Omnitram And 50 Mg Tramadol In Normal Human Subjects Made Cyp2d6 Deficient By Paroxetine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Syntrix Biosystems, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the analgesic effect of Omnitram and tramadol during concurrent administration of paroxetine. Paroxetine administration is expected to diminish the analgesic effect of tramadol, but not Omnitram. Each participant will receive paroxetine before and during treatment with Omnitram, tramadol, and placebo.

Detailed description

A randomized, double-blind, placebo-controlled study to investigating the steady-state oral pharmacokinetics and hypoalgesic effects of overencapsulated: 20 mg Omnitram (2x10 mg tablets), 50 mg tramadol (1x50 mg Ultram tablet), and placebo in male and female subjects made CYP2D6 deficient by paroxetine coadministration. Sixty participants in normal health, 18 to 50 years of age, who meet the entry criteria, will be randomized to one of the three treatments in treatment segment 1. Each arm will ingest three consecutive 20 mg daily doses of paroxetine. Twelve hours after the first paroxetine dose, subjects will be randomized to one of the treatment sequences to ingest a total of 9 doses of Omnitram, tramadol, or placebo (one dose every 6 hours). Immediately before the 9th dose a blood sample will be collected to quantify plasma Omnitram, tramadol, and paroxetine. After the 9th study drug dose, six blood samples will be collected (1.0, 1.5, 2.0, 2.5, 4.0, and 8.0 hours after the 9th dose is administered) to quantify the Omnitram and tramadol. After the 9th dose, pain tolerance will be assessed with a cold pressor test (immersion of hand in ice cold water). Participants will washout for 11-15 days after treatment 1 and treatment 2. The study will analyze treatment side effects, the pharmacokinetics, and pain tolerance.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Omnitram	Omnitram tablets overencapsulated
DRUG	Tramadol	Tramadol tablet overencapsulated
DRUG	Placebo	Microcrystalline powder overencapsulated

Timeline

• Start date: 2017-10-31
• Primary completion: 2017-12-15
• Completion: 2017-12-22
• First posted: 2017-10-18
• Last updated: 2017-12-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study