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Study Evaluating the Pharmacokinetic Profile of Novel Formulations of RHUDEX®

NCT01500122 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-06-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • MediGene

    lead INDUSTRY

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-03-31
Completion
2012-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01500122 on ClinicalTrials.gov