SAD/MAD PK and PD Study in Healthy Male Subjects

• Research type

  Research Study

• Full title

  TMX-049 - A Phase I, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects

• IRAS ID

  213704

• Contact name

  Sunu Valasseri

• Contact email

  sunu.valasseri@covance.com

• Sponsor organisation

  Teijin Pharma Limited

• Eudract number

  2016-001699-32

• Duration of Study in the UK

  0 years, 6 months, 1 days

• Research summary

  TMX-049 is an Investigational Medicinal Product (IMP) being developed for the treatment of gout and diabetic kidney disease.

  TMX-049 was well tolerated by healthy Japanese volunteers in a previous clinical trial with doses up to 120 mg in fasted condition. Single oral doses of 5 and 40 mg TMX-049 were also administered after a meal to investigate food effect.

  The principal aim of this study is to obtain safety and tolerability data when TMX-049 is administered orally as single and multiple doses to healthy male subjects of any ethnic origin.

  There are two parts for this study. In part A forty subjects will be studied in 5 groups (Groups A1 to A5), with each group consisting of 8 subjects. Each subject will participate in 1 treatment period only, residing at the Clinical Research Unit
  (CRU) from Day -2 (the day before baseline collections begin) to Day 4 (72 hours post-dose). The planned dose levels are 10 mg, 40 mg, 120 mg, 240 mg and 400 mg.

  All subjects will return for a post-study visit 6 to 8 days after their dose. In each of Groups A1 to A5 (and for the optional groups of subjects if studied), 6 subjects will receive TMX-049 and 2 subjects will receive placebo.

  In part B forty subjects will be studied in 5 groups (Groups B1 to B5), with each group consisting of 8 subjects. Each subject will participate in 1 treatment period only, residing at the CRU from Day -2 (the day before baseline collections begin) until the morning of Day 13 (72 hours after the final dose on Day 10).
  All subjects will return for a post-study visit 6 to 8 days after their final dose

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  16/NW/0693

• Date of REC Opinion

  26 Oct 2016

• REC opinion

  Further Information Favourable Opinion