NCT01500122

Study Evaluating the Pharmacokinetic Profile of Novel Formulations of RHUDEX®

An Open-label, Non Randomized Monocentric Phase I Study Evaluation the Pharmacokinetic Profile of Novel Formulations of RHUDEX®

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: MediGene · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objectives of the study are: * To compare the pharmacokinetic profiles of RhuDex administered as two novel oral formulations * To identify the lead formulation and optimise the pharmacokinetic profile by modifying the quantitative composition of that formulation * Optional: To assess the intravenous pharmacokinetics of RhuDex following administration of an IV microtracer of \[14C\]RhuDex

Conditions

• Formulation Finding

Interventions

Type	Name	Description
DRUG	RhuDex	Part 1: Regimen A: Rhudex Formulation in Labrafac/ Gelucire Regimen B: Rhudex Formulation in Labrafac/ Aerosil single dose The formulation platform (A or B) that shows the best potential to achieve the target PK profile and shows acceptable safety and tolerability will be progressed into part 2 of the study. The purpose of part 2 is to optimize the selected formulation platform. This will be achieved by administrating up to four different formulation compositions.

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-03-01
• Completion: 2012-06-01
• First posted: 2011-12-26
• Last updated: 2012-06-21

Locations

1 site across 1 country: United Kingdom