SMT19969 - A SAD/MAD, Safety, Tolerability & PK Study

• Research type

  Research Study

• Full title

  SMT19969 - A Phase I, Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Escalating Doses in Male Healthy Subjects

• IRAS ID

  110899

• Contact name

  Joseph Chiesa

• Sponsor organisation

  Summit Corporation plc.

• Eudract number

  2012-003451-10

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  SMT19969 is being developed as an oral antibiotic for the treatment of C. difficile infection. This is the first time SMT19969 will be administered to man. The proposed study will investigate the safety and tolerability of SMT19969 and will investigate how the body breaks down SMT19969 and how SMT19969 could affect the human body. The study has been arbitrarily divided into part 1 and 2. Part 1: 32 healthy male subjects will be studied in 4 groups (Groups A to D), each group consisting of 8 subjects. Subjects in Groups A, B and D will each participate in one treatment period receiving a single dose of SMT19969 or placebo. Subjects in Group C will participate in two treatment periods to assess the effect of food on SMT19969. Subjects will receive either a single dose of SMT19969 or placebo on Day 1 of each treatment period. Part 2: 16 subjects will be studied in 2 groups (Groups E & F). Subjects will participate in one treatment period and will receive multiple doses of either SMT19969 or placebo daily from Days 1 to 9 and a single dose on Day 10. A further group of 8 subjects (Group G) may be studied to explore alternative dosing regimens based on review of the Part 1 data. All subjects will check into the CRU the day before dosing and will remain resident until 72 hours after their last dose in Groups A, B, D and Treatment period 1 of Group C. In group E, F and G all subjects will check into the CRU two days before dosing and will remain resident until 48 hours after their last dose. While residing in the CRU subjects will be monitored for adverse events and changes in safety evaluations. Blood, urine and faecal samples will be taken for the measurement of drug concentrations. All subjects will be required to attend the CRU for a post study visit 5 to 7 days following their last dose.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  12/EE/0362

• Date of REC Opinion

  20 Sep 2012

• REC opinion

  Further Information Favourable Opinion