Dose level and food effect study of TSX-002 Testosterone.

• Research type

  Research Study

• Full title

  A Phase 1, 3 – Part Study to Identify the Optimal Therapeutic Dose Level by Evaluating the Pharmacokinetics and Safety of TSX-002 (Testosterone) in Hypogonadal Males and to Assess the Food Effect of TSX-002 at 2 Dose Levels followed by a Single Ascending Dose and a Multiple Dose Investigation.

• IRAS ID

  88016

• Contact name

  Stephen Smith

• Sponsor organisation

  TesoRx Pharma LLC.

• Eudract number

  2011-003305-24

• Research summary

  Male testosterone deficiency is an increasingly recognised medical condition. Testosterone replacement therapy is an accepted treatment for this. Normally additional testosterone cannot be given by mouth because of: 1) low absorption, and;2) extensive liver metabolism after absorption.Currently available commercial testosterone products address this problem by providing testosterone via other routes of administration (transdermal patches or gels, buccal adherent tablets, intramuscular injections, or implants) or by providing a chemical derivative of the testosterone molecule. TesoRx Pharma, LLC (TesoRx) has developed a novel approach for the oral administration of testosterone. TSX-002 is a new testosterone formulation that's absorbed into the blood by a different pathway that also helps reduce liver metabolism.This study aims to investigate:1) a dose schedule for TSX-002 that will produce medically useful concentrations of testosterone;2) the processing by the body of TSX-002, and;3) the effect of food on the absorption of TSX-002.Sixteen volunteers with documented low testosterone levels will take part in the study at one study site in Belfast, N. Ireland.

• REC name

  HSC REC A

• REC reference

  11/NI/0143

• Date of REC Opinion

  5 Oct 2011

• REC opinion

  Further Information Favourable Opinion