SAD/MAD Food Effect Study in Healthy Males and Females.

• Research type

  Research Study

• Full title

  SGM-1019 – A Phase I, Randomized, Placebo-Controlled, Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study with a Tablet Formulation of Micronized SGM 1019 in Healthy Male and Female Subjects

• IRAS ID

  209364

• Contact name

  Valasseri Sunu

• Contact email

  sunu.valasseri@covance.com

• Eudract number

  2016-002788-32

• Duration of Study in the UK

  0 years, 4 months, 23 days

• Research summary

  SGM 1019 is an Investigational Medicinal Product (IMP) being developed for the treatment of Ulcerative colitis
  SGM 1019 was well tolerated by healthy volunteers in a previous clinical trial with doses up to 1280 mg as an oral suspension and up to 160 mg as capsules.

  The main purpose of this study is to assess the safety and tolerability of single and multiple doses of micronized (increasing the solubility by reducing the particle size) tablet of SGM 1019.

  Part 1- Single ascending dose study with food effect evaluation. 32 subjects in 4 groups(A to D) with each group consisting of 8 subjects. Six will receive the test medication while two will receive placebo (dummy tablet). An additional three groups (upto 24 additional subjects) may be included.
  Subjects will participate in 1 treatment period and reside at the Unit from Day -1 (the day before dosing) to Day 5, except for Group B where each subject will participate in 2 treatment periods separated by a minimum of 14 days.
  Subjects will receive a single dose of SGM 1019 or placebo during the study. In Group B where subjects will have the same treatment in both treatment periods (Fed and fasted) .Each subject will receive 2 single doses of SGM 1019 or placebo during the study.

  Part 2 - Multiple ascending dose study. 36 subjects in 3 groups (Groups E to G), with each group consisting of 12 subjects (9 active and 3 placebo). The planned doses will be twice daily (BID) for 13 days, and once on Day 14. An additional group (12 additional subjects) may be included

  Each subject will participate in 1 treatment period and reside at the CRU from the evening of Day-1 until the morning of Day 16.

  All subjects will return for a post study visit 8 days after their final dose.

• REC name

  Wales REC 2

• REC reference

  16/WA/0227

• Date of REC Opinion

  30 Sep 2016

• REC opinion

  Further Information Favourable Opinion