Assessment of the safety and distribution of NVB302 in healthy volunteers

INTERVENTION: Part A (Single dose): Up to five cohorts of eight subjects will be randomized to receive one of five single oral doses of NVB302 with a starting dose of 100mg or a single oral dose of Placebo. The dose of NVB302 will be administered in an ascending dose fashion from Cohort 1 to 5. Within each cohort, 6 subjects will receive NVB302 and 2 subjects will receive placebo. Subjects will be followed up for 10 days Part B (Multiple dose): Up to four cohorts of eight subjects will be randomized to receive either 10 days of once daily oral doses of NVB302 (6 subjects) or 10 days of once daily oral doses of placebo (2 subjects). The dose range to be studied will be selected following review of the results from completed cohorts of Part A. Subjects will be followed up for a further 14 days CONDITION: Clostridium difficile infection ; Infections and Infestations ; Clostridium difficile infection PRIMARY OUTCOME: Safety: Measured by adverse events, vital signs, ECG and routine laboratory assessments. SECONDARY OUTCOME: Pharmacokinetic parameters: ; 1. Plasma: Cmax, Tmax, t½, AUC0‐t and AUC0; 2. Urine: Aeu (Amount of drug excreted); 3. Faeces: Aef (Amount of drug excreted) INCLUSION CRITERIA: 1. Healthy male and female subjects, between 18 and 64 years of age (inclusive) 2. Female subjects must be postmenopausal or surgically sterilised 3. Female subject of non‐child bearing potential with negative pregnancy test at screening 4. Male subjects must be willing to use an effective method of contraception from day 1 until 3 months afterwards 5. Subject has a healthy gastro‐intestinal (GI) tract with no clinically significant history of GI disease (including any disorder likely to influence drug absorption) or bowel surgery