Safety, Tolerability, PK and PD SAD assessment of PWT-143 (116998)

• Research type

  Research Study

• Full title

  Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of Various Formulations of PWT-143 in Healthy Subjects.

• IRAS ID

  177430

• Contact name

  Pui Leung

• Contact email

  pui.leung@quotientclinical.com

• Sponsor organisation

  MEI Pharma Inc

• Eudract number

  2015-001433-25

• Duration of Study in the UK

  0 years, 4 months, 6 days

• Research summary

  The Sponsor is developing the study drug, PWT-143, as a potential treatment for different types of lymphoma and leukaemia, which are forms of cancer that affect blood.

  This study will look at the safety of the study drug, how your body tolerates the drug and how the drug is taken up by your body when administered orally as single doses in different formulations

  The study will consist of 2 parts involving up to 35 healthy male subjects. Part 1, up to 27 subjects will be enrolled into 3 sequential groups, Group A, B and C, comprising of 3, 6, and 6 subjects respectively, with 2 optional groups (Groups D and E), of 6 subjects each. Part 2 up to 8 healthy male subjects will be enrolled and this will form a food effect study.

  Each subject will be administered a single dose of study drug across 2 study periods as follows:
  Group A: Dose levels 1 and 2 (PWT-143; 10 and 30 mg) using Formulation 1
  Group B: Either increasing dose level/s of the formulation dosed in Group A or a
  different formulation (Formulation 2 or 3) starting at 10 mg or any higher dose level previously given to subjects
  Group C: Either increasing dose level/s of the formulation dosed in Group A or a
  different formulation (Formulation 2 or 3) starting at 10 mg or any higher dose level previously given to subjects

  Dose levels and the formulation used in Groups B and C will be determined based on the emerging data from Group A, up to a maximum of 150mg.

  Part 2 will assess selected formulations of the study drug in the fed and fasted states. Dose levels and the formulation to be dosed for Part 2 will be determined based on the emerging data from Part 1
  

• REC name

  Wales REC 2

• REC reference

  15/WA/0162

• Date of REC Opinion

  22 May 2015

• REC opinion

  Favourable Opinion