Single & Multiple Escalating Doses of SMT C1100

• Research type

  Research Study

• Full title

  SMT C1100 - A Phase I, Double-Blind, Placebo Controlled, Ascending Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Subjects

• IRAS ID

  101881

• Contact name

  Brooks Ashley

• Sponsor organisation

  Summit Corporation plc

• Eudract number

  2012-000749-11

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study will investigate the safety, tolerability and pharmacokinetics (levels of drug in the blood) of single and multiple oral doses of SMT C1100, a new drug being developed for the treatment of Duchenne muscular dystrophy (DMD). The effects of food on the PK of SMT C1100 will also be investigated. DMD patients suffer muscle weakness and wastage and eventually will be confined to a wheelchair and will die prematurely. Part 1: Thirty two subjects will be studied in 4 groups of 8 subjects (Groups A to D). In Groups A, B and D, each subject will participate in 1 treatment period only and will receive a single dose of SMT C1100 or placebo. In Group C, each subject will participate in 2 treatment periods separated by a minimum of 7 days with subjects having the same treatment in both periods, such that each subject will receive two single doses of SMT C1100 or placebo during the study. All doses will be administered 30 minutes after a high fat breakfast in the morning of Day 1, except for Group C Treatment Period 2 where SMT C1100 or placebo will be given after an overnight fast. Part 2: Eight subjects will be studied in 1 group (Group E). Each subject will participate in 1 treatment period only, residing at the CRU from the evening of Day -1 until the morning of Day 12 (up to 48 hours after the final dose on Day 10). A further group of 8 subjects (Group F) may be studied to explore alternative dosing regimens, residing at the CRU from Day -1 to Day 12. All subjects in both Parts 1 and 2 will return for a short non-residential visit up to 72 hours post final dose.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0171

• Date of REC Opinion

  12 Apr 2012

• REC opinion

  Favourable Opinion