PAT-1251 SAD/MAD in Healthy Adult Subjects

• Research type

  Research Study

• Full title

  A Phase I, First in Human, Randomised, Placebo Controlled, Ascending Single and Multiple Dose Safety, Tolerability, Pharmacokinetic, and Food Effect Study of PAT 1251 in Healthy Adult Subjects

• IRAS ID

  206299

• Contact name

  Jim Bush

• Contact email

  Jim.Bush@covance.com

• Sponsor organisation

  PharmAkea Inc.

• Eudract number

  2016-001589-27

• Clinicaltrials.gov Identifier

  NCT02852551

• Duration of Study in the UK

  0 years, 5 months, 16 days

• Research summary

  PAT-1251 is an investigational medication which will be tested in humans (healthy male and female volunteers) for the first time.

  The study has 2 parts and will be double-blind (volunteers and investigators will not know who had the study drug) and placebo controlled (including an identical dummy pill). Which participants receive PAT-1251 or placebo will be randomly determined.

  Part A
  46 volunteers will be enrolled in 6 cohorts of 8 participants (A6- 6 participants).

  Each volunteer will receive only one dose of PAT-1251 or placebo and reside at the Clinical Research Unit from Day -1 (day before dosing) to Day 3, except in cohort A6 where each volunteer will participate in 2 treatment periods and reside at the Clinical Research Unit from Day -1 (day before dosing) to Day 3 of each treatment period. In cohort A6 each subject will receive one dose of PAT-1251 in each treatment period separated by a minimum of 6 days. In group A6 one dose will be given with food and one dose will be given fasting to see if food affects medication absorption.

  All subjects will return for post-study visits, 6 to 8 days after their final dose.

  Planned Dose Levels are 150, 450, 1000, 2000, and 4000mg.

  Part B
  32 volunteers will be studied in 4 cohorts of 8 participants.

  Each volunteer will participate in 1 treatment period and reside at the CRU from Day -1 until the morning of Day 9. Volunteers will attend for a post-study visit 6 to 8 days after their final dose. Each volunteer will receive 7 daily doses at a single dose level, which will not be greater than a level used in Part A.

  If emerging data indicate that further dose levels are necessary, 3 further cohorts may be added to each part.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  16/LO/0809

• Date of REC Opinion

  17 Jun 2016

• REC opinion

  Further Information Favourable Opinion